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Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Primary Purpose

Influenza

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baloxavir Marboxil
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

5 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

Index Patients (IPs):

  • Able to comply with the study protocol per investigator judgment.
  • Diagnosed with acute influenza infection by investigator.
  • Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results.
  • PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result
  • Presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
  • The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.
  • IP lives in a household where: (1) No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4 weeks; (2) All HHCs are expected to meet the key HHC inclusion criteria; (3) >=1 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening.
  • Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol

All HHCs (Part 1):

  • PCR (-) or RIDT (-) based on cobas® SARS-CoV-2 and influenza A/B or other local point-of-care / local laboratory result.
  • PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B or other POC / local laboratory result.
  • HHC lives with no HHC who will be present in the home at any time during the study and who meets any HHC exclusion criteria.
  • HHC lives with no HHC who does not meet HHC inclusion criteria (part 1).
  • HHC lives in a household where ≥1 HHCs meet all of the following: Start screening within 24 hours after IP randomization; Have NOT received the influenza vaccine within 6 months prior to screening; and Fulfill full study HHC inclusion criteria part 2.

Full study HHCs (part 2) intended for full study must meet the following additional criteria for study entry:

  • Agree to participate in the full study.
  • Able to comply with the study protocol per investigator judgment
  • No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a preexisting condition.
  • Temperature <38.0 °C (tympanic).
  • Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits.
  • Willing and able to measure and record temperature, or have another household member perform the task on his or her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors.
  • In the 6 months prior to screening: a) Has not been diagnosed with influenza by a healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine.
  • Does not have a moderate or worse active infections OR infections requiring systemic (e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled, intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild external infections allowed).

EXCLUSION CRITERIA:

IPs:

  • IPs with severe influenza virus infection requiring inpatient treatment.
  • IPs judged by the investigator to be at high risk for complications of influenza.
  • IP is ≥12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year olds who will receive oral suspension).
  • Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations.
  • IPs with concurrent (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
  • IPs who have received baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine, or an investigational drug, within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening.
  • IPs who have received an investigational monoclonal antibody for a viral disease in the last year.
  • Known hypersensitivity to baloxavir marboxil or the drug product excipients.
  • IP previously included in the study
  • IP lives with an HHC who, based on available information, meets the HHC exclusion criteria

HHC:

  • Pregnant or within 2 weeks post-partum at screening.
  • Immunocompromised.
  • Less than 2 years old.
  • Who have received an investigational therapy within the 30 days or 5 drug elimination half-lives, whichever is longer, prior to screening.
  • Diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks.
  • HHC who plans to arrive home after 24 hours post IP randomization to Day 9 and is not willing to be consented as soon as possible upon arrival.
  • HHC previously included in the study.

Sites / Locations

  • Central Alabama Research; Pediatrics
  • Cahaba Research, Inc.
  • Cahaba Research, Inc
  • Phoenix Clinical
  • Precision Trials
  • Alliance Urgent Care-Tolleson
  • Noble Clinical Research
  • Harrisburg Family Medical Center
  • Hope Clinical Research
  • Marvel Research, LLC
  • Long Beach Clinical Trials
  • Downtown LA Research Center
  • UCLA - School of Medicine
  • Probe Clinical Research
  • MD Strategies Research Centers
  • Cherry Creek Family Practice
  • Proactive Clinical Research, LLC
  • Alternative Research Associates, LLC
  • Helios Clinical Research, Inc (former Ventavia Research Group)
  • Canvas Clinical Research
  • South Florida Research Center, Inc.
  • Oceane7 Clinical Research
  • Cordova Research Institute, LLC
  • Premier Research Associate, Inc
  • Research Institute of South Florida Inc
  • Florida Research Center
  • CNS Healthcare
  • Nemours Children's Hospital; Nemour's Research InstituteRecruiting
  • Kendall South Medical Center Inc.
  • Clinical Trials of Florida LLC
  • Agile Clinical Research Trials
  • Clinical Research Prime
  • Medisphere Medical Research Center, Llc
  • Mishawaka Osteopathic Clinic
  • Kentucky Pediatric Research Center
  • Urgent Care Clinical Trials at Urgent Care Eleven
  • Claudia T Martorell MD LLC dba The Research Institute
  • Oakland Medical Research
  • Olive Branch Family Medical Center; Family Medicine
  • Washington University School of Medicine
  • Mercury Street Medical Group
  • Montana Medical Research LLC
  • Accent Clinical Trials
  • Excel Clinical Research
  • OnSite Clinical Solutions LLC
  • Burke Primary Care
  • Hometown Urgent Care and Occupational Health - Springdale
  • Hometown Urgent Care and Occupational Health - Clintonville
  • Dayton Clinical Research
  • Hometown Urgent Care and Research - Dayton
  • Tristar Clinical Investigations
  • Frontier Clinical Research
  • AFC Urgent Care-Easley
  • Jedda Enterprises dba Galen Clinical Research
  • Health Concepts
  • AFC Urgent Care-Gunbarrell
  • Urgent Care Clinical Trials at Complete Urgent Care
  • Pediatric Clinical Trials, LLC
  • ACRC Trials
  • City Doc Urgent Care-Dallas/Ft. Worth
  • Southwest Family Medicine Associates
  • Premier Pulmonary Critical Care and Sleep Medicine
  • Pioneer Research Solutions
  • Vilo Research Group
  • Mercury Clinical Research
  • Fairway Medical Clinic
  • Coastal Medical Group
  • Family Practice Center
  • Sun Research Institute
  • Sala Alberto Mignaburu
  • Centro Médico Dra de Salvo
  • Investigaciones en Patologias Respiratorias
  • CEMER Centro Medico de Enfermedades Respiratorias
  • Santa Casa de Misericordia; de Belo Horizonte
  • Centro Integrado de Oncologia de Curitiba
  • Hospital Moinhos de Vento
  • Dr. Consulta
  • Medical Centre "Asklepii", OOD; Office of Pulmonology and PhtisiatricsRecruiting
  • Medical Center Zdrave 1; Office of Pulmonology and Phtisiatrics
  • MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics
  • MHAT Stamen Iliev AD; Deparment of Infectious Diseases
  • MHAT Sveta Paraskeva; Office of Cardiology Diseases
  • Medical Center Nevrocentrum; Office of Pulmonology and PhtisiatricsRecruiting
  • SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov? EOOD; Department of PneumologyRecruiting
  • SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov?; Dept. of Pulmonology and PhtisiatricsRecruiting
  • Medizinski Zentrar-1-Sevlievo EOOD; Office of Pulmonology and Phtisiatrics
  • MHAT Sliven - Military Medial Academy; Department of Infectious Diseases
  • Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics
  • MHAT Sveta Sofia; Oncology DepartmentRecruiting
  • Clinica Vespucio
  • Centro de Cancer Pontificie Universidad Catolica de Chile
  • Capital Medical University Beijing Hospital of Traditional Chinese MedicineRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Beijing Children's Hospital, Capital Medical University
  • Beijing You An Hospital; Digestive Dept
  • Beijing Tsinghua Changgung HospitalRecruiting
  • Beijing Ditan HospitalRecruiting
  • Beijing Hospital of Ministry of Health
  • West China Hospital, Sichuan UniversityRecruiting
  • Childern's Hospital of Chongqing Medical UniversityRecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Guangzhou Women and Children's Medical CenterRecruiting
  • Liaocheng people's Hospital
  • Children's hospital of Nanjing medical universityRecruiting
  • The Third People's Hospital of Hainan Province
  • Huashan Hospital Affiliated to Fudan UniversityRecruiting
  • Zhongshan Hospital Fudan UniversityRecruiting
  • Shanghai Public Health Clinical Center
  • Shenzhen children's hospitalRecruiting
  • Shenzhen People's HospitalRecruiting
  • First Affiliated Hospital of Soochow University
  • Taizhou People's Hospital; Infectious DiseasesRecruiting
  • The First Affiliated Hospital of Wenzhou Medical CollegeRecruiting
  • Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Henan Provincial People's HospitalRecruiting
  • Zibo Municipal Hospital.Recruiting
  • ICIMED Instituto de Investigación en Ciencias Médicas
  • CH VICTOR DUPOUY; Reanimation Polyvalente
  • CHU de Grenoble - Hôpital André Michallon; Pôle UrgencesRecruiting
  • CHU Nantes - Hôtel Dieu; Urgences (Unité d'Investigation Clinique)
  • Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
  • Sotiria General Hospital of Athens; 3rd Department of Internal Medicine
  • Attikon University General Hospital; 4th Academic Department of Internal Medicine
  • Queen Mary Hospital; Uni Dept of Medicine, Division of Gastroenterology
  • Obudai Egeszsegugyi Centrum Kft.
  • Szigony utcai háziorvosi rendel? -Dr. Simon Judit
  • Háziorvosi praxis
  • II. Háziorvosi Körzet
  • Gyermekháziorvosi rendel?- Dr. Újhelyi János
  • Borbánya Praxis
  • Haziorvosi rendelo - Dr. Hasitz Agnes
  • Papp és Társa Bt.
  • III. Háziorvosi Körzet- Dr. Csomós Katalin
  • OEC Clinical Research
  • Sir Gangaram Hospital
  • Sterling Hospital; Clinical Research Department
  • Kanoria Hospital & Research Centre
  • Medanta-The Medicity
  • Apollo Hospitals
  • Mazumdar Shaw Medical Centre- A unit of Narayana Hrudayalaya
  • JSS Hospital; Department of clinical pharmacyRecruiting
  • Kasturba Medical College and Hospital; Department of Medicine
  • Sir J J Group of Hospitals; Department of Pulmonary Medicine
  • Criticare Hospital & Research Institute; Research department
  • Jehangir Clinical development Centre Pvt Ltd.
  • MTES's Sanjeevan Hospital
  • Lifepoint Multispeciality Hospital; Clinical research department.
  • JLN Medical College and Hospital; TB and Chest Department
  • AIG Hospitals
  • M.V Hospital and Research Centre; Research Hall
  • Ajanta Research centre; Research Department
  • Medical College and Hospital- Kolkata
  • Clalit Yud Aleph clinicRecruiting
  • Siaal Research Center for Family Medicine and Primary Care; Faculty of Health Sciences
  • Siaal Research Center for Family Medicine and Primary Care; Clalit Neve Zeev
  • Siaal Research Center for Family Medicine and Primary Care; Clalit Tet ClinicRecruiting
  • Kiryat Motzkin Maccabi Medical CenterRecruiting
  • Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic
  • Maccabi health services - Moked Hashalom; Maccabi health services - Moked Ramat Hasharon
  • Maccabi health services - Moked Hashalom
  • Toda Internal Medicine & Neurology ClinicRecruiting
  • Medical Corporation Houmankai?Umezu?ClinicRecruiting
  • Kashinoki Internal Medicine Clinic
  • Shin Komonji HospitalRecruiting
  • Fukuoka Shin Mizumaki HospitalRecruiting
  • Hatakeyama Internal Medicine and Gastroenterology Clinic
  • Fukuoka Wajiro HospitalRecruiting
  • Irie Naika Syounika IinRecruiting
  • Kimura Siro ClinicRecruiting
  • Kunisaki Makoto Clinic
  • Iguchi Clinic
  • Shimada Ear, Nose and Throat Clinic
  • Kyoaikai Hospital
  • Mashiba Clinic
  • Sawada Internal Medicine / Respiratory Clinic
  • Fujimaki Ent Clinic
  • Hisaki Family ClinicRecruiting
  • Nakamura Cardiovascular Clinic
  • Moriyama Otolaryngology
  • Kamoike ENT Allergy Clinic
  • Clinic KashiwanohaRecruiting
  • Kamezawa Clinic
  • Oishi Clinic
  • Takahashi naika
  • Kanagawa Himawari Clinic
  • Osaki Internal and Respiratory Clinic,
  • Morizono medical clinicRecruiting
  • Sato ENT Clinic
  • JA Kochi HospitalRecruiting
  • Kiheibashi Otolaryngology
  • Medical Corporation Association KANWAKAI Musashikoganei Clinic
  • Igarashi Internal Medicine Surgery Clinic
  • Medical corporation Shirayurikai Swing Nozaki ClinicRecruiting
  • Tanigawa Clinic
  • Yaesu Clinic
  • Horikawa ClinicRecruiting
  • Funai Ear Nose Throat ClinicRecruiting
  • Lee's Clinic
  • Manabe?ClinicRecruiting
  • Kitada Clinic
  • Sunami Internal medicine Clinic
  • Kikumori Ear, Nose and Throat Clinic
  • Saga Memorial HospitalRecruiting
  • Medical Corporation Saitadayoshikai Saikatsu Clinic
  • Segawa HospitalRecruiting
  • Okuda Ent Clinic
  • Uehara ClinicRecruiting
  • Aiiku Hospital
  • Hachiman Ishikawa internist clinic
  • Matsuo Kenko ClinicRecruiting
  • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
  • Soka sugiura Internal medicine clinicRecruiting
  • Wakasa ClinicRecruiting
  • Yamaichi Building Medical Clinic
  • Seiwa ClinicRecruiting
  • Miyazaki RC ClinicRecruiting
  • Sakayori Clinic
  • Sato Medical Clinic
  • Denenchofu Family ClinicRecruiting
  • Sato ClinicRecruiting
  • Suzuki internal & circulatory Medical Clinic
  • Sekino HospitalRecruiting
  • Takeru CLINIC
  • Tsuchiura Beryl Clinic
  • Medical corporation Seijinkai Takei Clinic
  • Gushiken-Cardiology and Internal medicineRecruiting
  • Uranishi Clinic
  • Mizoguchi Clinic
  • Tamura Medical Clinic
  • Yotsukaido Tokushukai Medical Center
  • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.Recruiting
  • Centro Respiratorio de MéxicoRecruiting
  • CEPREP; Hospital UniversitarioRecruiting
  • Centro de Estudios Clinicos de Queretaro (CECLIQ)Recruiting
  • EME REDRecruiting
  • Merida | Investigacion ClinicaRecruiting
  • Centro de Investigacion Clínica GRAMEL S.C
  • Lakeland Clinical Trials WaikatoRecruiting
  • Lakeland Clinical Trials RotoruaRecruiting
  • Lakeland Clinical Trials WellingtonRecruiting
  • KLIMED
  • KLIMED
  • KLIMED
  • NZOZ VitamedRecruiting
  • Centrum Medyczne Lukamed Joanna Luka
  • Anchor Meds - Kalisz
  • KO-MED Centra Kliniczne Lublin IIRecruiting
  • CM Luxmed Sp. z o.o.
  • Centrum Medyczne Pulawska SP. z o.o.
  • IRMED Osrodek Badan Klinicznych
  • KO-MED Centra Kliniczne Sp. z o.o.; Osrodek Badan KlinicznychRecruiting
  • RCMed
  • CLINHOUSE Sp z o.o.
  • KO-MED Centra Kliniczne ZamoscRecruiting
  • Fundacion de Investigacion de DiegoRecruiting
  • National University Hospital
  • National Healthcare Group Polyclinics- Yishun
  • Somerset West Clinical Trial Unit
  • TREAD Research
  • GAMA; Clinical Research
  • Into Research; Life Groenkloof Hospital Medical Centre
  • Newtown Clinical Research
  • Peermed Clinical Trial Centre
  • Trident Clinical
  • Langeberg Clinical TrialsRecruiting
  • Midrand Medical CentreRecruiting
  • Metropolitan Clinical Research Institute
  • Emmed Research
  • Setshaba Research Centre; Clinical Research
  • Dr As'ad Ebrahim Bhorat; Soweto Clinical Trial Centre
  • Wits Clinical Research
  • Limpopo Clinical Research Initiative; Tamboti Medical CentreRecruiting
  • Welkom Clinical Trial Centre
  • Centro de Salud Las Aguilas; Medicina GeneralRecruiting
  • Ankara University Medical Faculty
  • Diskapi Egitim Ve Arastirma Hastanesi; Infection
  • Ankara Bilkent City HospitalRecruiting
  • Gazi University Medical FacultyRecruiting
  • Ankara University Faculty of Medicine Cebeci HospitalRecruiting
  • Hacettepe University Medical Faculty; Infectious Diseases
  • Hacettepe University Medical Faculty; Infectious Diseases
  • Akdeniz University Medical FacultyRecruiting
  • Koc University Medical Faculty; Department of Gynecology & Obstetrics
  • Istanbul Uni Istanbul Medical Faculty
  • Atakent Acibadem Private Hosptial Halkali Merkez Mh.,Recruiting
  • Ege University Medical FacultyRecruiting
  • Dokuz Eylul University Medical Faculty; InfectionRecruiting
  • Kocaeli University Medical Faculty
  • Karadeniz Technical Uni School of Medicine; Infection Diseases & Clinical Mikrobiology DeptRecruiting
  • The Haven Surgery
  • Staploe Medical Centre
  • Preston Hill Surgery
  • Knowle House Surgery
  • The Village Practice; Thornton Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baloxavir Marboxil

Placebo

Arm Description

Participants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.

Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.

Outcomes

Primary Outcome Measures

Virological Transmission by Day 5
Defined as the percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 post IP randomization. HHCs may be symptomatic or asymptomatic and their virus subtype must match that of the index patient (IP) in their household. The primary efficacy analysis population will consist of all enrolled unvaccinated HHCs of the randomized IPs.

Secondary Outcome Measures

Symptomatic Transmission by Day 5
Defined as the percentage of HHCs who become PCR+ for Influenza by Day 5 post IP randomization and develop Influenza symptoms at any time during the study. HHCs ≥12 years old were defined symptomatic if (1) Presence of temperature ≥38.0 Celsius and one respiratory symptom (cough, sore throat, nasal congestion) or (2) Presence of one respiratory symptom and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and <12 years old were defined symptomatic if presence of temperature ≥38.0 Celsius and cough, nasal congestion, or rhinorrhea. Note: For HHCs of any age, respiratory or general systemic symptoms had to be either (1) new, or (2) worsened versus baseline with baseline symptoms due to a pre-existing comorbidity. HHCs must have their virus subtype match that of the IP.
Virological Transmission at the Household Level by Day 5
Defined as the percentage of households with at least one HHC who meets the primary endpoint.
Symptomatic Transmission at the Household Level by Day 5
Defined as the percentage of households with at least one HHC who meets the "Symptomatic transmission by Day 5 endpoint.
Virological Transmission by Day 9
Defined as the percentage of HHCs who become PCR+ for Influenza by Day 9 post IP randomization. HHCs must have their virus subtype match that of the IP, and include: (1) all HHC meeting primary endpoint, AND (2) all HHC cases detected after Day 5 Visit meeting the following criteria: (2a) included HHC case is in a household where another HHC has already met the primary endpoint, OR (2b) included HHC case is PCR (+) for influenza bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein, that have been associated with reduced susceptibility to baloxavir marboxil.
Symptomatic Transmission by Day 9
Defined as the percentage of HHCs who meet the "Virological transmission by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Any Virological Infection by Day 9
Defined as the percentage of HHCs who become PCR (+) for influenza (confirmed at central laboratory) by Day 9.
Any Virological Infection at the Household Level by Day 9
Defined as the percentage of households with at least one HHC who meets the "Any virological infection by Day 9" endpoint.
Any Symptomatic Infection by Day 9
Defined as the percentage of HHCs who meet the "Any virological infection by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Any Symptomatic Infection at the Household Level by Day 9
Defined as the percentage of households with at least one HHC who meets the "Any symptomatic infection by Day 9" endpoint.
Percentage of IPs With Adverse Events (AEs)
Percentage of IPs (<= 12 years old) Reporting each Palatability and Acceptability Response
The Palatability and Acceptability questionnaire consists of 2 questions: 1) How was the taste of this medicine; 2) Would you be happy to take this medicine again. Response for question (1) will be captured on a Likert scale (1-5) and for question (2) will be either Yes, No, or Not Sure/No Answer.

Full Information

First Posted
May 29, 2019
Last Updated
October 13, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03969212
Brief Title
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Official Title
A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baloxavir Marboxil
Arm Type
Experimental
Arm Description
Participants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.
Intervention Type
Drug
Intervention Name(s)
Baloxavir Marboxil
Other Intervention Name(s)
Xofluza
Intervention Description
IPs less than 12 years old will receive either 2 mg/kg (if weight less than 20 kg) or 40 mg (if weight more than or equal to 20 kg) of Baloxavir Marboxil as oral suspension. IPs more than or equal to 12 years old will receive either 40 mg (if weight less than 80 kg) or 80 mg (if weight more than or equal to 80 kg) of Baloxavir Marboxil as tablets. HHCs of IPs will not receive study medication.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IPs less than 12 years old will receive placebo oral suspension and those above 12 years will receive placebo tablets. HHCs of IPs will not receive study medication.
Primary Outcome Measure Information:
Title
Virological Transmission by Day 5
Description
Defined as the percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 post IP randomization. HHCs may be symptomatic or asymptomatic and their virus subtype must match that of the index patient (IP) in their household. The primary efficacy analysis population will consist of all enrolled unvaccinated HHCs of the randomized IPs.
Time Frame
Baseline to Day 5 (5 days)
Secondary Outcome Measure Information:
Title
Symptomatic Transmission by Day 5
Description
Defined as the percentage of HHCs who become PCR+ for Influenza by Day 5 post IP randomization and develop Influenza symptoms at any time during the study. HHCs ≥12 years old were defined symptomatic if (1) Presence of temperature ≥38.0 Celsius and one respiratory symptom (cough, sore throat, nasal congestion) or (2) Presence of one respiratory symptom and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and <12 years old were defined symptomatic if presence of temperature ≥38.0 Celsius and cough, nasal congestion, or rhinorrhea. Note: For HHCs of any age, respiratory or general systemic symptoms had to be either (1) new, or (2) worsened versus baseline with baseline symptoms due to a pre-existing comorbidity. HHCs must have their virus subtype match that of the IP.
Time Frame
Baseline to Day 5 (5 days)
Title
Virological Transmission at the Household Level by Day 5
Description
Defined as the percentage of households with at least one HHC who meets the primary endpoint.
Time Frame
Baseline to Day 5 (5 days)
Title
Symptomatic Transmission at the Household Level by Day 5
Description
Defined as the percentage of households with at least one HHC who meets the "Symptomatic transmission by Day 5 endpoint.
Time Frame
Baseline to Day 5 (5 days)
Title
Virological Transmission by Day 9
Description
Defined as the percentage of HHCs who become PCR+ for Influenza by Day 9 post IP randomization. HHCs must have their virus subtype match that of the IP, and include: (1) all HHC meeting primary endpoint, AND (2) all HHC cases detected after Day 5 Visit meeting the following criteria: (2a) included HHC case is in a household where another HHC has already met the primary endpoint, OR (2b) included HHC case is PCR (+) for influenza bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein, that have been associated with reduced susceptibility to baloxavir marboxil.
Time Frame
Baseline to Day 9 (9 days)
Title
Symptomatic Transmission by Day 9
Description
Defined as the percentage of HHCs who meet the "Virological transmission by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Time Frame
Baseline to Day 9 (9 Days)
Title
Any Virological Infection by Day 9
Description
Defined as the percentage of HHCs who become PCR (+) for influenza (confirmed at central laboratory) by Day 9.
Time Frame
Baseline to Day 9 (9 Days)
Title
Any Virological Infection at the Household Level by Day 9
Description
Defined as the percentage of households with at least one HHC who meets the "Any virological infection by Day 9" endpoint.
Time Frame
Baseline to Day 9 (9 Days)
Title
Any Symptomatic Infection by Day 9
Description
Defined as the percentage of HHCs who meet the "Any virological infection by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Time Frame
Baseline to Day 9 (9 Days)
Title
Any Symptomatic Infection at the Household Level by Day 9
Description
Defined as the percentage of households with at least one HHC who meets the "Any symptomatic infection by Day 9" endpoint.
Time Frame
Baseline to Day 9 (9 Days)
Title
Percentage of IPs With Adverse Events (AEs)
Time Frame
Baseline to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old)
Title
Percentage of IPs (<= 12 years old) Reporting each Palatability and Acceptability Response
Description
The Palatability and Acceptability questionnaire consists of 2 questions: 1) How was the taste of this medicine; 2) Would you be happy to take this medicine again. Response for question (1) will be captured on a Likert scale (1-5) and for question (2) will be either Yes, No, or Not Sure/No Answer.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Index Patients (IPs): Able to comply with the study protocol per investigator judgment. Diagnosed with acute influenza infection by investigator. Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results. PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result Presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue). The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less. IP lives in a household where: (1) No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4 weeks; (2) All HHCs are expected to meet the key HHC inclusion criteria; (3) >=1 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening. Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol All HHCs (Part 1): PCR (-) or RIDT (-) based on cobas® SARS-CoV-2 and influenza A/B or other local point-of-care / local laboratory result. PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B or other POC / local laboratory result. HHC lives with no HHC who will be present in the home at any time during the study and who meets any HHC exclusion criteria. HHC lives with no HHC who does not meet HHC inclusion criteria (part 1). HHC lives in a household where ≥1 HHCs meet all of the following: Start screening within 24 hours after IP randomization; Have NOT received the influenza vaccine within 6 months prior to screening; and Fulfill full study HHC inclusion criteria part 2. Full study HHCs (part 2) intended for full study must meet the following additional criteria for study entry: Agree to participate in the full study. Able to comply with the study protocol per investigator judgment No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a preexisting condition. Temperature <38.0 °C (tympanic). Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits. Willing and able to measure and record temperature, or have another household member perform the task on his or her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors. In the 6 months prior to screening: a) Has not been diagnosed with influenza by a healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine. Does not have a moderate or worse active infections OR infections requiring systemic (e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled, intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild external infections allowed). EXCLUSION CRITERIA: IPs: IPs with severe influenza virus infection requiring inpatient treatment. IPs judged by the investigator to be at high risk for complications of influenza. IP is ≥12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year olds who will receive oral suspension). Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations. IPs with concurrent (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations. IPs who have received baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine, or an investigational drug, within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening. IPs who have received an investigational monoclonal antibody for a viral disease in the last year. Known hypersensitivity to baloxavir marboxil or the drug product excipients. IP previously included in the study IP lives with an HHC who, based on available information, meets the HHC exclusion criteria HHC: Pregnant or within 2 weeks post-partum at screening. Immunocompromised. Less than 2 years old. Who have received an investigational therapy within the 30 days or 5 drug elimination half-lives, whichever is longer, prior to screening. Diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks. HHC who plans to arrive home after 24 hours post IP randomization to Day 9 and is not willing to be consented as soon as possible upon arrival. HHC previously included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MV40618 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Central Alabama Research; Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Completed
Facility Name
Cahaba Research, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Completed
Facility Name
Cahaba Research, Inc
City
Pelham
State/Province
Alabama
ZIP/Postal Code
35124
Country
United States
Individual Site Status
Completed
Facility Name
Phoenix Clinical
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Individual Site Status
Withdrawn
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Completed
Facility Name
Alliance Urgent Care-Tolleson
City
Tolleson
State/Province
Arizona
ZIP/Postal Code
85353
Country
United States
Individual Site Status
Withdrawn
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Withdrawn
Facility Name
Harrisburg Family Medical Center
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Completed
Facility Name
Marvel Research, LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Withdrawn
Facility Name
Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Completed
Facility Name
Downtown LA Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Completed
Facility Name
UCLA - School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Withdrawn
Facility Name
Probe Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Individual Site Status
Completed
Facility Name
MD Strategies Research Centers
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Individual Site Status
Completed
Facility Name
Cherry Creek Family Practice
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Individual Site Status
Withdrawn
Facility Name
Proactive Clinical Research, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Completed
Facility Name
Alternative Research Associates, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Withdrawn
Facility Name
Helios Clinical Research, Inc (former Ventavia Research Group)
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Individual Site Status
Completed
Facility Name
Canvas Clinical Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Withdrawn
Facility Name
South Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Completed
Facility Name
Oceane7 Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cordova Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Completed
Facility Name
Premier Research Associate, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Institute of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Completed
Facility Name
Florida Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Withdrawn
Facility Name
CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Withdrawn
Facility Name
Nemours Children's Hospital; Nemour's Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Name
Kendall South Medical Center Inc.
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Trials of Florida LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Withdrawn
Facility Name
Agile Clinical Research Trials
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Completed
Facility Name
Medisphere Medical Research Center, Llc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mishawaka Osteopathic Clinic
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Individual Site Status
Completed
Facility Name
Kentucky Pediatric Research Center
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Individual Site Status
Withdrawn
Facility Name
Urgent Care Clinical Trials at Urgent Care Eleven
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70771
Country
United States
Individual Site Status
Withdrawn
Facility Name
Claudia T Martorell MD LLC dba The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oakland Medical Research
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Completed
Facility Name
Olive Branch Family Medical Center; Family Medicine
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Individual Site Status
Withdrawn
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Completed
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Completed
Facility Name
Montana Medical Research LLC
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Individual Site Status
Completed
Facility Name
Accent Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Individual Site Status
Completed
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Completed
Facility Name
OnSite Clinical Solutions LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Completed
Facility Name
Burke Primary Care
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Individual Site Status
Completed
Facility Name
Hometown Urgent Care and Occupational Health - Springdale
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Individual Site Status
Completed
Facility Name
Hometown Urgent Care and Occupational Health - Clintonville
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Withdrawn
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hometown Urgent Care and Research - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tristar Clinical Investigations
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Completed
Facility Name
Frontier Clinical Research
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Completed
Facility Name
AFC Urgent Care-Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Individual Site Status
Withdrawn
Facility Name
Jedda Enterprises dba Galen Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Individual Site Status
Withdrawn
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Withdrawn
Facility Name
AFC Urgent Care-Gunbarrell
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Completed
Facility Name
Urgent Care Clinical Trials at Complete Urgent Care
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pediatric Clinical Trials, LLC
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Individual Site Status
Withdrawn
Facility Name
ACRC Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Individual Site Status
Withdrawn
Facility Name
City Doc Urgent Care-Dallas/Ft. Worth
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Individual Site Status
Completed
Facility Name
Southwest Family Medicine Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Completed
Facility Name
Premier Pulmonary Critical Care and Sleep Medicine
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
077099
Country
United States
Individual Site Status
Completed
Facility Name
Vilo Research Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77017
Country
United States
Individual Site Status
Completed
Facility Name
Mercury Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77036-3316
Country
United States
Individual Site Status
Completed
Facility Name
Fairway Medical Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Individual Site Status
Completed
Facility Name
Coastal Medical Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77089-6155
Country
United States
Individual Site Status
Withdrawn
Facility Name
Family Practice Center
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Completed
Facility Name
Sala Alberto Mignaburu
City
Berazategui
ZIP/Postal Code
B1878FNR
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Centro Médico Dra de Salvo
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Investigaciones en Patologias Respiratorias
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IAR
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
CEMER Centro Medico de Enfermedades Respiratorias
City
Vicente López
ZIP/Postal Code
B1602DQD
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Centro Integrado de Oncologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80810-050
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-000
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Dr. Consulta
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01141-020
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Medical Centre "Asklepii", OOD; Office of Pulmonology and Phtisiatrics
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Zdrave 1; Office of Pulmonology and Phtisiatrics
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
MHAT Stamen Iliev AD; Deparment of Infectious Diseases
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
MHAT Sveta Paraskeva; Office of Cardiology Diseases
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Nevrocentrum; Office of Pulmonology and Phtisiatrics
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov? EOOD; Department of Pneumology
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov?; Dept. of Pulmonology and Phtisiatrics
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medizinski Zentrar-1-Sevlievo EOOD; Office of Pulmonology and Phtisiatrics
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
MHAT Sliven - Military Medial Academy; Department of Infectious Diseases
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
MHAT Sveta Sofia; Oncology Department
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinica Vespucio
City
Santiago
ZIP/Postal Code
8241479
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Centro de Cancer Pontificie Universidad Catolica de Chile
City
Santiago
ZIP/Postal Code
8330074
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Capital Medical University Beijing Hospital of Traditional Chinese Medicine
City
Beijing City
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing City
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing City
ZIP/Postal Code
100045
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing You An Hospital; Digestive Dept
City
Beijing City
ZIP/Postal Code
100069
Country
China
Individual Site Status
Completed
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing City
ZIP/Postal Code
102218
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Ditan Hospital
City
Beijing
ZIP/Postal Code
100011
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Hospital of Ministry of Health
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Withdrawn
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Childern's Hospital of Chongqing Medical University
City
Chongqing City
ZIP/Postal Code
401122
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
ZIP/Postal Code
510623
Country
China
Individual Site Status
Recruiting
Facility Name
Liaocheng people's Hospital
City
Liaocheng City
ZIP/Postal Code
252000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Children's hospital of Nanjing medical university
City
Nanjing City
ZIP/Postal Code
210001
Country
China
Individual Site Status
Recruiting
Facility Name
The Third People's Hospital of Hainan Province
City
Sanya
ZIP/Postal Code
572000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
ZIP/Postal Code
201508
Country
China
Individual Site Status
Withdrawn
Facility Name
Shenzhen children's hospital
City
Shenzhen City
ZIP/Postal Code
518038
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen People's Hospital
City
Shenzhen
ZIP/Postal Code
510852
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Withdrawn
Facility Name
Taizhou People's Hospital; Infectious Diseases
City
Taizhou City
ZIP/Postal Code
225309
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Name
Zibo Municipal Hospital.
City
ZIbo
ZIP/Postal Code
255400
Country
China
Individual Site Status
Recruiting
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San José
ZIP/Postal Code
10108
Country
Costa Rica
Individual Site Status
Terminated
Facility Name
CH VICTOR DUPOUY; Reanimation Polyvalente
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU de Grenoble - Hôpital André Michallon; Pôle Urgences
City
LA Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nantes - Hôtel Dieu; Urgences (Unité d'Investigation Clinique)
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Withdrawn
Facility Name
Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Completed
Facility Name
Sotiria General Hospital of Athens; 3rd Department of Internal Medicine
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Completed
Facility Name
Attikon University General Hospital; 4th Academic Department of Internal Medicine
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Completed
Facility Name
Queen Mary Hospital; Uni Dept of Medicine, Division of Gastroenterology
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Completed
Facility Name
Szigony utcai háziorvosi rendel? -Dr. Simon Judit
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Háziorvosi praxis
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
II. Háziorvosi Körzet
City
Hosszúhetény
ZIP/Postal Code
7694
Country
Hungary
Individual Site Status
Completed
Facility Name
Gyermekháziorvosi rendel?- Dr. Újhelyi János
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Completed
Facility Name
Borbánya Praxis
City
Nyíregyháza
ZIP/Postal Code
4405
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Haziorvosi rendelo - Dr. Hasitz Agnes
City
Szentendre
ZIP/Postal Code
2000
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Papp és Társa Bt.
City
Szigetvár
ZIP/Postal Code
7900
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
III. Háziorvosi Körzet- Dr. Csomós Katalin
City
Sátoraljaújhely
ZIP/Postal Code
3980
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
OEC Clinical Research
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Completed
Facility Name
Sir Gangaram Hospital
City
NEW Delhi Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Completed
Facility Name
Sterling Hospital; Clinical Research Department
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
Individual Site Status
Completed
Facility Name
Kanoria Hospital & Research Centre
City
Gandhi Nagar
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Medanta-The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Individual Site Status
Completed
Facility Name
Apollo Hospitals
City
Bangalore South
State/Province
Karnataka
ZIP/Postal Code
560076
Country
India
Individual Site Status
Completed
Facility Name
Mazumdar Shaw Medical Centre- A unit of Narayana Hrudayalaya
City
Bangalore South
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Individual Site Status
Completed
Facility Name
JSS Hospital; Department of clinical pharmacy
City
Mysuru
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Individual Site Status
Recruiting
Facility Name
Kasturba Medical College and Hospital; Department of Medicine
City
Udupi
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Sir J J Group of Hospitals; Department of Pulmonary Medicine
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Individual Site Status
Completed
Facility Name
Criticare Hospital & Research Institute; Research department
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Jehangir Clinical development Centre Pvt Ltd.
City
Pune City
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Active, not recruiting
Facility Name
MTES's Sanjeevan Hospital
City
Pune City
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Lifepoint Multispeciality Hospital; Clinical research department.
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411057
Country
India
Individual Site Status
Completed
Facility Name
JLN Medical College and Hospital; TB and Chest Department
City
Ajmer
State/Province
Rajasthan
ZIP/Postal Code
305001
Country
India
Individual Site Status
Completed
Facility Name
AIG Hospitals
City
Gachibowli
State/Province
Telangana
ZIP/Postal Code
500032
Country
India
Individual Site Status
Completed
Facility Name
M.V Hospital and Research Centre; Research Hall
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Individual Site Status
Completed
Facility Name
Ajanta Research centre; Research Department
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226005
Country
India
Individual Site Status
Completed
Facility Name
Medical College and Hospital- Kolkata
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700073
Country
India
Individual Site Status
Completed
Facility Name
Clalit Yud Aleph clinic
City
Beer Sheva
ZIP/Postal Code
8476109
Country
Israel
Individual Site Status
Recruiting
Facility Name
Siaal Research Center for Family Medicine and Primary Care; Faculty of Health Sciences
City
Beer-Sheva
ZIP/Postal Code
8410500
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Siaal Research Center for Family Medicine and Primary Care; Clalit Neve Zeev
City
Beer-Sheva
ZIP/Postal Code
8425842
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Siaal Research Center for Family Medicine and Primary Care; Clalit Tet Clinic
City
Beer-Sheva
ZIP/Postal Code
8477713
Country
Israel
Individual Site Status
Recruiting
Facility Name
Kiryat Motzkin Maccabi Medical Center
City
Kiryat Motzkin
ZIP/Postal Code
6971028
Country
Israel
Individual Site Status
Recruiting
Facility Name
Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic
City
Petach Tikva
ZIP/Postal Code
4931807
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Maccabi health services - Moked Hashalom; Maccabi health services - Moked Ramat Hasharon
City
Ramat Hasharon
ZIP/Postal Code
6971028
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Maccabi health services - Moked Hashalom
City
Tel Aviv
ZIP/Postal Code
6789140
Country
Israel
Individual Site Status
Terminated
Facility Name
Toda Internal Medicine & Neurology Clinic
City
Akashi
ZIP/Postal Code
674-0081
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation Houmankai?Umezu?Clinic
City
Chikushino
ZIP/Postal Code
818-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kashinoki Internal Medicine Clinic
City
Date
ZIP/Postal Code
960-0418
Country
Japan
Individual Site Status
Completed
Facility Name
Shin Komonji Hospital
City
Fukuoka
ZIP/Postal Code
800-0057
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka Shin Mizumaki Hospital
City
Fukuoka
ZIP/Postal Code
807-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hatakeyama Internal Medicine and Gastroenterology Clinic
City
Fukuoka
ZIP/Postal Code
810?0024
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Fukuoka Wajiro Hospital
City
Fukuoka
ZIP/Postal Code
811-0213
Country
Japan
Individual Site Status
Recruiting
Facility Name
Irie Naika Syounika Iin
City
Fukuoka
ZIP/Postal Code
812-0053
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kimura Siro Clinic
City
Fukuoka
ZIP/Postal Code
819-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kunisaki Makoto Clinic
City
Fukuoka
ZIP/Postal Code
819-0168
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Iguchi Clinic
City
Fukuyama
ZIP/Postal Code
720-0825
Country
Japan
Individual Site Status
Completed
Facility Name
Shimada Ear, Nose and Throat Clinic
City
Habikino
ZIP/Postal Code
583-0886
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Kyoaikai Hospital
City
Hakodate
ZIP/Postal Code
040-8577
Country
Japan
Individual Site Status
Completed
Facility Name
Mashiba Clinic
City
Hanno
ZIP/Postal Code
357-0024
Country
Japan
Individual Site Status
Terminated
Facility Name
Sawada Internal Medicine / Respiratory Clinic
City
Himeji
ZIP/Postal Code
670-0942
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Fujimaki Ent Clinic
City
Ichikawa
ZIP/Postal Code
272-0143
Country
Japan
Individual Site Status
Completed
Facility Name
Hisaki Family Clinic
City
Ichikawa
ZIP/Postal Code
272-0805
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nakamura Cardiovascular Clinic
City
Itoshima
ZIP/Postal Code
819-1104
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Moriyama Otolaryngology
City
Kagoshima
ZIP/Postal Code
890-0034
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kamoike ENT Allergy Clinic
City
Kagoshima
ZIP/Postal Code
890-0063
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Clinic Kashiwanoha
City
Kashiwa
ZIP/Postal Code
277-0882
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kamezawa Clinic
City
Kasugai
ZIP/Postal Code
486-0817
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Oishi Clinic
City
Kasuyagun
ZIP/Postal Code
811-2310
Country
Japan
Individual Site Status
Completed
Facility Name
Takahashi naika
City
Kawasaki
ZIP/Postal Code
211-0041
Country
Japan
Individual Site Status
Completed
Facility Name
Kanagawa Himawari Clinic
City
Kawasaki
ZIP/Postal Code
216-0006
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaki Internal and Respiratory Clinic,
City
Kitakyushu
ZIP/Postal Code
802-0083
Country
Japan
Individual Site Status
Terminated
Facility Name
Morizono medical clinic
City
Kitakyushu
ZIP/Postal Code
807-0072
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sato ENT Clinic
City
Kitakyushu
ZIP/Postal Code
807-0856
Country
Japan
Individual Site Status
Completed
Facility Name
JA Kochi Hospital
City
Kochi
ZIP/Postal Code
783-8509
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kiheibashi Otolaryngology
City
Kodaira
ZIP/Postal Code
187-0044
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Medical Corporation Association KANWAKAI Musashikoganei Clinic
City
Koganei
ZIP/Postal Code
184-0004
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Igarashi Internal Medicine Surgery Clinic
City
Koriyama
ZIP/Postal Code
963-8026
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Medical corporation Shirayurikai Swing Nozaki Clinic
City
Musashino
ZIP/Postal Code
180-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tanigawa Clinic
City
Nagasaki
ZIP/Postal Code
852-8137
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Yaesu Clinic
City
Naha
ZIP/Postal Code
900-0032
Country
Japan
Individual Site Status
Terminated
Facility Name
Horikawa Clinic
City
Nonoichi
ZIP/Postal Code
921-8801
Country
Japan
Individual Site Status
Recruiting
Facility Name
Funai Ear Nose Throat Clinic
City
Oita
ZIP/Postal Code
870-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Lee's Clinic
City
Osaka
ZIP/Postal Code
531-0073
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Manabe?Clinic
City
Osaka
ZIP/Postal Code
533-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitada Clinic
City
Osaka
ZIP/Postal Code
538-0044
Country
Japan
Individual Site Status
Terminated
Facility Name
Sunami Internal medicine Clinic
City
Osaka
ZIP/Postal Code
538-0044
Country
Japan
Individual Site Status
Terminated
Facility Name
Kikumori Ear, Nose and Throat Clinic
City
Osaka
ZIP/Postal Code
554-0014
Country
Japan
Individual Site Status
Completed
Facility Name
Saga Memorial Hospital
City
Saga
ZIP/Postal Code
849-0917
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation Saitadayoshikai Saikatsu Clinic
City
Saitama
ZIP/Postal Code
342-0037
Country
Japan
Individual Site Status
Completed
Facility Name
Segawa Hospital
City
Saitama
ZIP/Postal Code
355-0328
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okuda Ent Clinic
City
Sakai
ZIP/Postal Code
593-8322
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Uehara Clinic
City
Sapporo
ZIP/Postal Code
006-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aiiku Hospital
City
Sapporo
ZIP/Postal Code
064-0804
Country
Japan
Individual Site Status
Terminated
Facility Name
Hachiman Ishikawa internist clinic
City
Sendai
ZIP/Postal Code
980-0871
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Matsuo Kenko Clinic
City
Sendai
ZIP/Postal Code
981-0907
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
City
Shinagawa
ZIP/Postal Code
140-8522
Country
Japan
Individual Site Status
Completed
Facility Name
Soka sugiura Internal medicine clinic
City
Soka
ZIP/Postal Code
340-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wakasa Clinic
City
Tokorozawa
ZIP/Postal Code
359-1151
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamaichi Building Medical Clinic
City
Tokyo
ZIP/Postal Code
121-0815
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Seiwa Clinic
City
Tokyo
ZIP/Postal Code
123-0845
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyazaki RC Clinic
City
Tokyo
ZIP/Postal Code
140-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sakayori Clinic
City
Tokyo
ZIP/Postal Code
140-0011
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Sato Medical Clinic
City
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Denenchofu Family Clinic
City
Tokyo
ZIP/Postal Code
145-0071
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sato Clinic
City
Tokyo
ZIP/Postal Code
150-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Suzuki internal & circulatory Medical Clinic
City
Tokyo
ZIP/Postal Code
154-0024
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Sekino Hospital
City
Toshima
ZIP/Postal Code
171-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takeru CLINIC
City
Toyohashi
ZIP/Postal Code
440-0834
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tsuchiura Beryl Clinic
City
Tsuchiura
ZIP/Postal Code
300-0062
Country
Japan
Individual Site Status
Completed
Facility Name
Medical corporation Seijinkai Takei Clinic
City
Tsuru
ZIP/Postal Code
402-0025
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Gushiken-Cardiology and Internal medicine
City
Urasoe
ZIP/Postal Code
901-2102
Country
Japan
Individual Site Status
Recruiting
Facility Name
Uranishi Clinic
City
Urasoe
ZIP/Postal Code
901-2104
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Mizoguchi Clinic
City
YAO
ZIP/Postal Code
581-0069
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Tamura Medical Clinic
City
Yokohama
ZIP/Postal Code
226-0025
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Yotsukaido Tokushukai Medical Center
City
Yotsukaido
ZIP/Postal Code
284-0032
Country
Japan
Individual Site Status
Completed
Facility Name
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro Respiratorio de México
City
Mexico
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Recruiting
Facility Name
CEPREP; Hospital Universitario
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Estudios Clinicos de Queretaro (CECLIQ)
City
Querétaro
State/Province
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
EME RED
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Merida | Investigacion Clinica
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97125
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Clínica GRAMEL S.C
City
Mexico
ZIP/Postal Code
03720
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Lakeland Clinical Trials Waikato
City
Hamilton
ZIP/Postal Code
3200
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Lakeland Clinical Trials Rotorua
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Lakeland Clinical Trials Wellington
City
Wellington
ZIP/Postal Code
5018
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
KLIMED
City
Bia?ystok
ZIP/Postal Code
15-704
Country
Poland
Individual Site Status
Completed
Facility Name
KLIMED
City
Bia?ystok
ZIP/Postal Code
15-704
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
KLIMED
City
Bia?ystok
ZIP/Postal Code
15-704
Country
Poland
Individual Site Status
Withdrawn
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Lukamed Joanna Luka
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Individual Site Status
Completed
Facility Name
Anchor Meds - Kalisz
City
Kalisz
ZIP/Postal Code
62-800
Country
Poland
Individual Site Status
Completed
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Individual Site Status
Recruiting
Facility Name
CM Luxmed Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-400
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Centrum Medyczne Pulawska SP. z o.o.
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
IRMED Osrodek Badan Klinicznych
City
Piotrków Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
KO-MED Centra Kliniczne Sp. z o.o.; Osrodek Badan Klinicznych
City
Pu?awy
ZIP/Postal Code
24-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
RCMed
City
Warszawa
ZIP/Postal Code
00-892
Country
Poland
Individual Site Status
Withdrawn
Facility Name
CLINHOUSE Sp z o.o.
City
Zabrze
ZIP/Postal Code
41-807
Country
Poland
Individual Site Status
Completed
Facility Name
KO-MED Centra Kliniczne Zamosc
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
National Healthcare Group Polyclinics- Yishun
City
Singapore
ZIP/Postal Code
768898
Country
Singapore
Individual Site Status
Completed
Facility Name
Somerset West Clinical Trial Unit
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Individual Site Status
Suspended
Facility Name
TREAD Research
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
GAMA; Clinical Research
City
Germiston
ZIP/Postal Code
1401
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Into Research; Life Groenkloof Hospital Medical Centre
City
Groenkloof
ZIP/Postal Code
0181
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Newtown Clinical Research
City
Johannesburg
ZIP/Postal Code
2113
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Peermed Clinical Trial Centre
City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Trident Clinical
City
Kimberley
ZIP/Postal Code
8301
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Langeberg Clinical Trials
City
Kraaifontein
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Midrand Medical Centre
City
Midrand
ZIP/Postal Code
1685
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Metropolitan Clinical Research Institute
City
Polokwane
ZIP/Postal Code
0699
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Setshaba Research Centre; Clinical Research
City
Pretoria
ZIP/Postal Code
0152
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Dr As'ad Ebrahim Bhorat; Soweto Clinical Trial Centre
City
Soweto
ZIP/Postal Code
1818
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Wits Clinical Research
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Limpopo Clinical Research Initiative; Tamboti Medical Centre
City
Tabazimbi
ZIP/Postal Code
0380
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Welkom Clinical Trial Centre
City
Welkom
ZIP/Postal Code
9460
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Centro de Salud Las Aguilas; Medicina General
City
Madrid
ZIP/Postal Code
28044
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Diskapi Egitim Ve Arastirma Hastanesi; Infection
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara University Faculty of Medicine Cebeci Hospital
City
Ankara
ZIP/Postal Code
06700
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty; Infectious Diseases
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Hacettepe University Medical Faculty; Infectious Diseases
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Individual Site Status
Completed
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Koc University Medical Faculty; Department of Gynecology & Obstetrics
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Completed
Facility Name
Istanbul Uni Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul University Medical Faculty; Infection
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Completed
Facility Name
Karadeniz Technical Uni School of Medicine; Infection Diseases & Clinical Mikrobiology Dept
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
The Haven Surgery
City
Durham
ZIP/Postal Code
DH7 0BD
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Staploe Medical Centre
City
Ely
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Preston Hill Surgery
City
Harrow
ZIP/Postal Code
HA3 9SN
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Knowle House Surgery
City
Plymouth
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
The Village Practice; Thornton Medical Centre
City
Thornton-Cleveleys
ZIP/Postal Code
FY5 2TZ
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)
Citations:
PubMed Identifier
33103200
Citation
Komeda T, Takazono T, Hosogaya N, Ogura E, Fujiwara M, Miyauchi H, Ajisawa Y, Iwata S, Watanabe H, Honda K, Kitanishi Y, Hara K, Mukae H. Comparison of Household Transmission of Influenza Virus From Index Patients Treated With Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study. Clin Infect Dis. 2021 Jun 1;72(11):e859-e867. doi: 10.1093/cid/ciaa1622.
Results Reference
derived

Learn more about this trial

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

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