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A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors (COMMODORE 1)

Primary Purpose

Paroxysmal Nocturnal Hemoglobinuria

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

About this trial

This is an interventional treatment trial for Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body weight >= 40 kg at screening.
  • Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.
  • Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening.
  • Willingness and ability to comply with all study visits and procedures.
  • Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
  • Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration.
  • Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 6 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label).

Exclusion Criteria:

  • History of allogeneic bone marrow transplantation.
  • History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high.
  • Pregnant or breastfeeding, or intending to become pregnant during the study, within 6 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label).
  • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment.
  • Positive for Active Hepatitis B and C infection (HBV/HCV).
  • Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study.
  • History of or ongoing cryoglobulinemia at screening.

Sites / Locations

  • The Oncology Institute of Hope and Innovation
  • David Geffen School of Medicine UCLARecruiting
  • Indiana Blood & Marrow Transplantation, LLCRecruiting
  • Henry Ford HospitalRecruiting
  • Carolinas Healthcare SystemRecruiting
  • Nationwide Children's Hospital; Dept. of PulmonologyRecruiting
  • Cook Childrens Medical CenterRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting
  • Liverpool HospitalRecruiting
  • Westmead HospitalRecruiting
  • Royal Perth HospitalRecruiting
  • Cliniques Universitaires Saint-Luc; PharmacyRecruiting
  • AZ Delta Campus WestlaanRecruiting
  • CHU UCL Namur / site GodinneRecruiting
  • Hospital Universitario Walter Cantidio - UFCRecruiting
  • Nucleo de Pesquisa Clinica do Hospital da CriancaRecruiting
  • Chronos Pesquisa ClinicaRecruiting
  • Elo Clinical Research
  • Centro Integrado de Oncologia de CuritibaRecruiting
  • Hrpc - Health Clinical Research Representation - Eireli
  • Santa Casa de Misericordia de Porto AlegreRecruiting
  • Hospital de Clínicas de Porto Alegre X
  • Instituto Joinvilense de Hematologia E OncologiaRecruiting
  • Fundação Doutor Amaral CarvalhoRecruiting
  • Hospital das Clínicas FMRP-USP
  • *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e OncologiaRecruiting
  • Hospital Sírio-Libanês
  • Hospital PaulistanoRecruiting
  • Beneficencia Portuguesa de Sao PauloRecruiting
  • CISSS Chaudière-AppalachesRecruiting
  • Fundacion Santa Fe de Bogota
  • Ustav hematologie a krevni transfuzeRecruiting
  • North Estonia Medical Centre FoundationRecruiting
  • Hopital Claude Huriez - CHU LilleRecruiting
  • Institut Paoli Calmette; Service d'Hématologie CliniqueRecruiting
  • CHU Rennes - Hopital Pontchaillou; Service d'Hémostase BiocliniqueRecruiting
  • Universitaetsklinikum Aachen AOeRRecruiting
  • UniversitaetsklinikumRecruiting
  • ELBLANDKLINIKUM RiesaRecruiting
  • Universitaetsklinikum UlmRecruiting
  • University General Hospital of AlexandroupolisRecruiting
  • General Hospital of Athens LAIKORecruiting
  • Attikon University General HospitalRecruiting
  • University General Hospital of LarissaRecruiting
  • General Hospital of Thessaloniki G. PapanikolaouRecruiting
  • The Chinese University of Hong KongRecruiting
  • Semmelweis EgyetemRecruiting
  • St James's HospitalRecruiting
  • Azienda Ospedaliera San Giuseppe Moscati
  • Azienda Unita Sanitaria Locale- RavennaRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
  • Fondazione IRCCS CA? Granda Ospedale Maggiore PoliclinicoRecruiting
  • Azienda Ospedaliera Città della Salute e della Scienza di TorinoRecruiting
  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
  • Azienda Ospedaliera Universitaria CareggiRecruiting
  • Fujita Health University HospitalRecruiting
  • Fukushima Medical University HospitalRecruiting
  • Sapporo Medical University Hospital
  • Kobe University Hospital; Medical Oncology and HematologyRecruiting
  • Tokushukai Takasago Seibu HospitalRecruiting
  • University of Tsukuba Hospital
  • Ishikawa Prefectural Central Hospital
  • Tokai University HospitalRecruiting
  • Mie University Hospital
  • Japanese Red Cross Society Suwa Hospital
  • Nagasaki University HospitalRecruiting
  • Sasebo City General HospitalRecruiting
  • National Hospital Organization Okayama Medical Center
  • Osaka University HospitalRecruiting
  • Iwate Prefectural Isawa Hospital
  • NTT Medical Center TokyoRecruiting
  • Tokyo Medical University Hospital
  • Toyama Prefectual Central Hospital
  • Seoul National University HospitalRecruiting
  • Severance Hospital; Yonsei University Health SystemRecruiting
  • Asan Medical Center
  • Samsung Medical CenterRecruiting
  • Ulsan University HospitalRecruiting
  • Amsterdam UMC, Locatie AMCRecruiting
  • Szpital Uniwersytecki nr2 im. dr J. BizielaRecruiting
  • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i TransplantologiiRecruiting
  • SPZOZ Szpital Uniw W KrakowieRecruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 1Recruiting
  • Centrum Medyczne Pratia PoznanRecruiting
  • MTZ Clinical Research Powered by PratiaRecruiting
  • Centro Hospitalar do Porto - Hospital de Santo AntónioRecruiting
  • King Faisal Specialist Hospital & Research CenterRecruiting
  • National University HospitalRecruiting
  • ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia ClinicaRecruiting
  • Hospital Sant Joan De DeuRecruiting
  • Complejo Hospitalario Universitario de Santiago.Recruiting
  • Hospital Universitario de Gran CanariaRecruiting
  • Hospital de BasurtoRecruiting
  • Hospital U. Central de AsturiasRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinic de Barcelona
  • Hospital San Pedro de AlcantaraRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario Clinico San CarlosRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Complejo Hospitalario de ToledoRecruiting
  • Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
  • Hospital Universitario Miguel ServetRecruiting
  • Akademiska SjukhusetRecruiting
  • Changhua Christian HospitalRecruiting
  • Hualien Tzu Chi Hospital; Hematology and oncologyRecruiting
  • Chi Mei Medical Center Liou Ying Campus
  • National Taiwan Universtiy Hospital; Division of HematologyRecruiting
  • MacKay Memorial Hospital; Hematology and oncology
  • Hacettepe University Medical Faculty; NeurologyRecruiting
  • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; HematologyRecruiting
  • Istanbul University Istanbul Medical Faculty; NeurologyRecruiting
  • Marmara University Pendik Training and Research Hospital, Hematology DepartmentRecruiting
  • Ege University Medical Faculty; HematologyRecruiting
  • Ondokuz Mayis Univ. Med. Fac.Recruiting
  • King'S College Hospital; HaematologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm A (Crovalimab)

Arm B (Eculizumab)

Arm C (Crovalimab) (Exploratory)

Arm Description

Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.

Participants will receive an approved maintenance dose of eculizumab starting on Day 1 and Q2W (every 2 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of study eculizumab treatment, participants will have the option to switch to crovalimab or to discontinue from the study after completion of 10 weeks of safety follow-up.

Participants will receive a loading series of Crovalimab comprised of an IV dose on Week 1 Day 1, followed by weekly crovalimab SC doses for 4 weeks on Week 1 (Day 2) then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will be administered Q4W thereafter. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs) and by Severity
Determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5).
Percentage of Participants with Injection- Site Reactions, Infusion-Related Reactions, Hypersensitivity and Infections (including Meningococcal Meningitis)
Percentage of Participants with Adverse Events (AEs) Leading to Study Drug Discontinuation
Percentage of Participants with Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Those Participants who Switched to Crovalimab Treatment from Eculizumab Treatment or Ravulizumab Treatment

Secondary Outcome Measures

Serum Concentrations of Crovalimab or Eculizumab Over Time
Serum Concentrations of Ravulizumab at the time of Crovalimab Initiation
Percentage of Participants with Anti-Crovalimab Antibodies
Change in Pharmacodynamic (PD) Biomarker Complement Activity (CH50) Over Time
Change Over Time in Free C5 Concentration in Crovalimab-Treated Participants
Observed Value in Reticulocyte Count (count/mL)
Observed Value in Free Hemoglobin and Haptoglobin (mg/dL)
Change in Reticulocyte Count (count/mL)
Absolute Change in Free Hemoglobin and Haptoglobin (mg/dL)

Full Information

First Posted
June 3, 2020
Last Updated
October 3, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04432584
Brief Title
A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Acronym
COMMODORE 1
Official Title
A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Safety, Pharmacokinetics, Pharmacodynamic And Efficacy of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
September 1, 2029 (Anticipated)
Study Completion Date
September 1, 2029 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Nocturnal Hemoglobinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Crovalimab)
Arm Type
Experimental
Arm Description
Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.
Arm Title
Arm B (Eculizumab)
Arm Type
Active Comparator
Arm Description
Participants will receive an approved maintenance dose of eculizumab starting on Day 1 and Q2W (every 2 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of study eculizumab treatment, participants will have the option to switch to crovalimab or to discontinue from the study after completion of 10 weeks of safety follow-up.
Arm Title
Arm C (Crovalimab) (Exploratory)
Arm Type
Experimental
Arm Description
Participants will receive a loading series of Crovalimab comprised of an IV dose on Week 1 Day 1, followed by weekly crovalimab SC doses for 4 weeks on Week 1 (Day 2) then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will be administered Q4W thereafter. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.
Intervention Type
Drug
Intervention Name(s)
Crovalimab
Intervention Description
Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.
Intervention Type
Drug
Intervention Name(s)
Eculizumab
Intervention Description
Eculizumab will be administered at a dose of 900 mg every 2 weeks, as per the dosing schedule described above.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs) and by Severity
Description
Determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5).
Time Frame
Up to approximately 8 years
Title
Percentage of Participants with Injection- Site Reactions, Infusion-Related Reactions, Hypersensitivity and Infections (including Meningococcal Meningitis)
Time Frame
Up to approximately 8 years
Title
Percentage of Participants with Adverse Events (AEs) Leading to Study Drug Discontinuation
Time Frame
Up to approximately 8 years
Title
Percentage of Participants with Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Those Participants who Switched to Crovalimab Treatment from Eculizumab Treatment or Ravulizumab Treatment
Time Frame
Up to approximately 8 years
Secondary Outcome Measure Information:
Title
Serum Concentrations of Crovalimab or Eculizumab Over Time
Time Frame
Up to approximately 8 years
Title
Serum Concentrations of Ravulizumab at the time of Crovalimab Initiation
Time Frame
Baseline
Title
Percentage of Participants with Anti-Crovalimab Antibodies
Time Frame
Up to approximately 8 years
Title
Change in Pharmacodynamic (PD) Biomarker Complement Activity (CH50) Over Time
Time Frame
Up to approximately 8 years
Title
Change Over Time in Free C5 Concentration in Crovalimab-Treated Participants
Time Frame
Up to approximately 8 years
Title
Observed Value in Reticulocyte Count (count/mL)
Time Frame
Up to approximately 8 years
Title
Observed Value in Free Hemoglobin and Haptoglobin (mg/dL)
Time Frame
Up to approximately 8 years
Title
Change in Reticulocyte Count (count/mL)
Time Frame
Baseline up to Week 25
Title
Absolute Change in Free Hemoglobin and Haptoglobin (mg/dL)
Time Frame
Baseline up to Week 25

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body weight >= 40 kg at screening. Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1. Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening. Willingness and ability to comply with all study visits and procedures. Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry. Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration. Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label). Exclusion Criteria: History of allogeneic bone marrow transplantation. History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high. Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label). Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment. Positive for Active Hepatitis B and C infection (HBV/HCV). Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study. History of or ongoing cryoglobulinemia at screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO42161 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
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
The Oncology Institute of Hope and Innovation
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
David Geffen School of Medicine UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana Blood & Marrow Transplantation, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Individual Site Status
Recruiting
Facility Name
Nationwide Children's Hospital; Dept. of Pulmonology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Name
Cook Childrens Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc; Pharmacy
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta Campus Westlaan
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur / site Godinne
City
Yvoir
ZIP/Postal Code
B5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Walter Cantidio - UFC
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60430-370
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Nucleo de Pesquisa Clinica do Hospital da Crianca
City
Brasilia
State/Province
DF
ZIP/Postal Code
70684-831
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Chronos Pesquisa Clinica
City
Taguatinga
State/Province
DF
ZIP/Postal Code
72145-450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Elo Clinical Research
City
Maringa
State/Province
PA
ZIP/Postal Code
87015-200
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
Recruiting
Facility Name
Hrpc - Health Clinical Research Representation - Eireli
City
Canoas
State/Province
RS
ZIP/Postal Code
92010-170
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clínicas de Porto Alegre X
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto Joinvilense de Hematologia E Oncologia
City
Joinville
State/Province
SC
ZIP/Postal Code
89201-260
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundação Doutor Amaral Carvalho
City
JAU
State/Province
SP
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clínicas FMRP-USP
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Paulistano
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01321-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Beneficencia Portuguesa de Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01321-00
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CISSS Chaudière-Appalaches
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fundacion Santa Fe de Bogota
City
Bogota
ZIP/Postal Code
110111
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Ustav hematologie a krevni transfuze
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Hopital Claude Huriez - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Paoli Calmette; Service d'Hématologie Clinique
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique
City
Rennes cedex 9
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Aachen AOeR
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
ELBLANDKLINIKUM Riesa
City
Riesa
ZIP/Postal Code
01589
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
University General Hospital of Alexandroupolis
City
Alexandroupolis
ZIP/Postal Code
681 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens LAIKO
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon University General Hospital
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
412 21
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Thessaloniki G. Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Name
The Chinese University of Hong Kong
City
Shatin
ZIP/Postal Code
123456
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Giuseppe Moscati
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Unita Sanitaria Locale- Ravenna
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Molise
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital
City
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Medical University Hospital
City
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Kobe University Hospital; Medical Oncology and Hematology
City
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokushukai Takasago Seibu Hospital
City
Hyogo
ZIP/Postal Code
676-0812
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Ishikawa Prefectural Central Hospital
City
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital
City
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Japanese Red Cross Society Suwa Hospital
City
Nagano
ZIP/Postal Code
392-8510
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sasebo City General Hospital
City
Nagasaki
ZIP/Postal Code
857-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Prefectural Isawa Hospital
City
Oshu
ZIP/Postal Code
023-0864
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
NTT Medical Center Tokyo
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Completed
Facility Name
Toyama Prefectual Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital; Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Amsterdam UMC, Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki nr2 im. dr J. Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPZOZ Szpital Uniw W Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Poznan
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
MTZ Clinical Research Powered by Pratia
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
Individual Site Status
Recruiting
Facility Name
ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan De Deu
City
Esplugues De Llobregas
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago.
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
5ºA
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Gran Canaria
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35019
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital U. Central de Asturias
City
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario de Toledo
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital
City
Chang Hua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Hualien Tzu Chi Hospital; Hematology and oncology
City
Hualien City
ZIP/Postal Code
97002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi Mei Medical Center Liou Ying Campus
City
Liuying Township
ZIP/Postal Code
736
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
National Taiwan Universtiy Hospital; Division of Hematology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
MacKay Memorial Hospital; Hematology and oncology
City
Zhongshan Dist.
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Istanbul Medical Faculty; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara University Pendik Training and Research Hospital, Hematology Department
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty; Hematology
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
King'S College Hospital; Haematology
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting

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).

Learn more about this trial

A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

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