Back to resultsStudy to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
Primary Purpose
Hepatitis C Virus (HCV)
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glecaprevir/Pibrentasvir (GLE/PIB)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus (HCV) focused on measuring Acute HCV Infection, HCV Genotype 1-6, Hepatitis C, Glecaprevir/Pibrentasvir, ABT-493/ABT-530, Mavyret
Eligibility Criteria
Inclusion Criteria:
Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV RNA at screening, and at least 1 of the following:
- Negative anti-HCV antibody, HCV Ribonucleic Acid (RNA) and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
- Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
- Clinical signs and symptoms compatible with acute hepatitis [Alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) and/or jaundice] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
- Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
- Absence of hepatocellular carcinoma (HCC), for participants with cirrhosis, or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
- Participants documented as having no cirrhosis or as having compensated cirrhosis.
Exclusion Criteria:
- Participants with prior treatment, including interferon for this HCV infection.
- History of liver decompensation.
Sites / Locations
- Arizona Health Research /ID# 233558Recruiting
- The Institute for Liver Health /ID# 228427
- Liver Wellness Center /ID# 244933Recruiting
- AHF Research Center /ID# 254795Recruiting
- Velocity Clinical Research Chula Vista /ID# 238352
- AHF Healthcare Center- Hollywood /ID# 254794Recruiting
- TLC Clinical Research Inc /ID# 232334Recruiting
- University of California, Davis Comprehensive Cancer Center /ID# 230814Recruiting
- Angels Clinical Research Institute /ID# 234090Recruiting
- AIDS Healthcare Foundation - Northpoint /ID# 254814Recruiting
- Midway Immunology and Research Center /ID# 229194Recruiting
- Midland Research Group, Inc /ID# 231885
- Orlando Immunology Center /ID# 229839Recruiting
- Tampa General Hospital /ID# 228930Recruiting
- Triple O Research Institute /ID# 229928
- Florida Medical Clinic /ID# 233489
- Emory Midtown Infectious Disease Clinic /ID# 229927Recruiting
- University of Iowa Hospitals and Clinics /ID# 226934Recruiting
- University of Kentucky Chandler Medical Center /ID# 231588
- University of Louisville Research Foundation Inc /ID# 232139Recruiting
- Mercy Medical Center /ID# 226937
- Johns Hopkins University /ID# 230694Recruiting
- Henry Ford Health System /ID# 226932Recruiting
- University of Mississippi Medical Center /ID# 232620Recruiting
- Las Vegas Research Center /ID# 255631Recruiting
- North Jersey Community Research Initiative (NJCRI) /ID# 245129Recruiting
- Weill Cornell Medical College /ID# 230815Recruiting
- Coastal Research Institute, LLC /ID# 233233Recruiting
- The Christ Hospital /ID# 231204Recruiting
- University of Cincinnati /ID# 226922Recruiting
- Cherokee Nation Outpatient Health Center /ID# 232618
- Thomas Jefferson University /ID# 232624Recruiting
- University Gastroenterology /ID# 233332
- Vanderbilt University Medical Center /ID# 241282Recruiting
- Liver Associates of Texas, P.A /ID# 229775Recruiting
- Digestive and Liver Disease Sp /ID# 232633Recruiting
- Medical College of Wisconsin - Plank Rd /ID# 230116Recruiting
- Royal Adelaide Hospital /ID# 227167
- Alfred Health /ID# 227169Recruiting
- Universitaetsklinikum St. Poelten /ID# 227098Recruiting
- Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985
- Medizinische Universitaet Wien /ID# 226938Recruiting
- Vancouver Infectious Diseases Centre /ID# 227125Recruiting
- CoolAid Medical Clinic /ID# 239978Recruiting
- Charlton Medical Centre /ID# 228100Recruiting
- Royal Victoria Hospital / McGill University Health Centre /ID# 227126Recruiting
- CHU Montpellier - Hôpital Saint Eloi /ID# 229083Recruiting
- Hopital Beaujon /ID# 246817Recruiting
- CH de Tourcoing /ID# 233732Recruiting
- HCL - Hopital de la Croix-Rousse /ID# 229077Recruiting
- AP-HP - Hopital Saint-Antoine /ID# 229070Recruiting
- zibp-Zentrum fuer Infektiologie /ID# 226765Recruiting
- Universitaetsklinikum Bonn /ID# 226764Recruiting
- Klinikum Dortmund gGmbH /ID# 249689Recruiting
- Infektiologikum /ID# 226880Recruiting
- ICH Study Center GmbH & Co KG /ID# 228162Recruiting
- Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783Recruiting
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080Recruiting
- Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081Recruiting
- ASST Grande Ospedale Metropolitano Niguarda /ID# 227079Recruiting
- Azienda Ospedaliera Universitaria Federico II /ID# 227183Recruiting
- Hospital Universitario Germans Trias i Pujol /ID# 226698Recruiting
- Hospital Parc de Salut del Mar /ID# 226696Recruiting
- Hospital Clinic de Barcelona /ID# 226695Recruiting
- Centro Sanitario Sandoval /ID# 226954Recruiting
- Hospital Universitario Infanta Leonor /ID# 251780Recruiting
- Hospital General Universitario de Valencia /ID# 226709
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks
Arm Description
Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population
SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.
Secondary Outcome Measures
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population.
SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population
On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.
Percentage of Participants With Post-Treatment Relapse in the ITT Population
Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.
Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population
Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04903626
Brief Title
Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
Official Title
A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
April 5, 2024 (Anticipated)
Study Completion Date
April 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.
GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.
Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus (HCV)
Keywords
Acute HCV Infection, HCV Genotype 1-6, Hepatitis C, Glecaprevir/Pibrentasvir, ABT-493/ABT-530, Mavyret
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
283 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks
Arm Type
Experimental
Arm Description
Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir (GLE/PIB)
Other Intervention Name(s)
ABT-493/ABT-530, Mavyret
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population
Description
SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.
Time Frame
12 weeks after last dose of study drug (Week 20)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population.
Description
SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.
Time Frame
12 weeks after last dose of study drug (Week 20)
Title
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population
Description
On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.
Time Frame
Up to week 8
Title
Percentage of Participants With Post-Treatment Relapse in the ITT Population
Description
Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.
Time Frame
Up to 12 weeks after the last dose of study drug (Week 20)
Title
Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population
Description
Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.
Time Frame
Up to 12 weeks after the last dose of study drug (Week 20)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV RNA at screening, and at least 1 of the following:
Negative anti-HCV antibody, HCV Ribonucleic Acid (RNA) and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
Clinical signs and symptoms compatible with acute hepatitis [Alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) and/or jaundice] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
Absence of hepatocellular carcinoma (HCC), for participants with cirrhosis, or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
Participants documented as having no cirrhosis or as having compensated cirrhosis.
Exclusion Criteria:
Participants with prior treatment, including interferon for this HCV infection.
History of liver decompensation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Health Research /ID# 233558
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225-2906
Country
United States
Individual Site Status
Recruiting
Facility Name
The Institute for Liver Health /ID# 228427
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Completed
Facility Name
Liver Wellness Center /ID# 244933
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Individual Site Status
Recruiting
Facility Name
AHF Research Center /ID# 254795
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research Chula Vista /ID# 238352
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911-6658
Country
United States
Individual Site Status
Completed
Facility Name
AHF Healthcare Center- Hollywood /ID# 254794
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
TLC Clinical Research Inc /ID# 232334
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of California, Davis Comprehensive Cancer Center /ID# 230814
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Angels Clinical Research Institute /ID# 234090
City
Doral
State/Province
Florida
ZIP/Postal Code
33122-1713
Country
United States
Individual Site Status
Recruiting
Facility Name
AIDS Healthcare Foundation - Northpoint /ID# 254814
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Midway Immunology and Research Center /ID# 229194
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Individual Site Status
Recruiting
Facility Name
Midland Research Group, Inc /ID# 231885
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334-4434
Country
United States
Individual Site Status
Completed
Facility Name
Orlando Immunology Center /ID# 229839
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Tampa General Hospital /ID# 228930
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Triple O Research Institute /ID# 229928
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3100
Country
United States
Individual Site Status
Completed
Facility Name
Florida Medical Clinic /ID# 233489
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Individual Site Status
Completed
Facility Name
Emory Midtown Infectious Disease Clinic /ID# 229927
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospitals and Clinics /ID# 226934
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky Chandler Medical Center /ID# 231588
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Completed
Facility Name
University of Louisville Research Foundation Inc /ID# 232139
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Mercy Medical Center /ID# 226937
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Completed
Facility Name
Johns Hopkins University /ID# 230694
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Henry Ford Health System /ID# 226932
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Mississippi Medical Center /ID# 232620
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4500
Country
United States
Individual Site Status
Recruiting
Facility Name
Las Vegas Research Center /ID# 255631
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
North Jersey Community Research Initiative (NJCRI) /ID# 245129
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-2842
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College /ID# 230815
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Coastal Research Institute, LLC /ID# 233233
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Individual Site Status
Recruiting
Facility Name
The Christ Hospital /ID# 231204
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of Cincinnati /ID# 226922
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Individual Site Status
Recruiting
Facility Name
Cherokee Nation Outpatient Health Center /ID# 232618
City
Tahlequah
State/Province
Oklahoma
ZIP/Postal Code
74464-0545
Country
United States
Individual Site Status
Completed
Facility Name
Thomas Jefferson University /ID# 232624
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Individual Site Status
Recruiting
Facility Name
University Gastroenterology /ID# 233332
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center /ID# 241282
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Individual Site Status
Recruiting
Facility Name
Liver Associates of Texas, P.A /ID# 229775
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2783
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive and Liver Disease Sp /ID# 232633
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin - Plank Rd /ID# 230116
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Royal Adelaide Hospital /ID# 227167
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Completed
Facility Name
Alfred Health /ID# 227169
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum St. Poelten /ID# 227098
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Completed
Facility Name
Medizinische Universitaet Wien /ID# 226938
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Vancouver Infectious Diseases Centre /ID# 227125
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Individual Site Status
Recruiting
Facility Name
CoolAid Medical Clinic /ID# 239978
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8W 1M8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Charlton Medical Centre /ID# 228100
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Victoria Hospital / McGill University Health Centre /ID# 227126
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 229083
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Beaujon /ID# 246817
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Name
CH de Tourcoing /ID# 233732
City
TOURCOING Cedex
State/Province
Nord
ZIP/Postal Code
59208
Country
France
Individual Site Status
Recruiting
Facility Name
HCL - Hopital de la Croix-Rousse /ID# 229077
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Saint-Antoine /ID# 229070
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
zibp-Zentrum fuer Infektiologie /ID# 226765
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Bonn /ID# 226764
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Dortmund gGmbH /ID# 249689
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Infektiologikum /ID# 226880
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Name
ICH Study Center GmbH & Co KG /ID# 228162
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda /ID# 227079
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Federico II /ID# 227183
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 226698
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Parc de Salut del Mar /ID# 226696
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona /ID# 226695
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Sanitario Sandoval /ID# 226954
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Infanta Leonor /ID# 251780
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia /ID# 226709
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
We'll reach out to this number within 24 hrs