Status:
COMPLETED
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)
Lead Sponsor:
AbbVie
Conditions:
Hepatitis C Virus (HCV)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- Evidence of acute HCV infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV ribonucleic Acid (RNA) at screening, and at least 1 of the following:
- Negative anti-HCV antibody, HCV 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
- Participants with prior treatment, including interferon for this HCV infection.
- History of liver decompensation.
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2024
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT04903626
Start Date
August 24 2021
End Date
September 17 2024
Last Update
April 6 2025
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Health Research /ID# 233558
Chandler, Arizona, United States, 85225-2906
2
The Institute for Liver Health /ID# 228427
Peoria, Arizona, United States, 85381
3
Liver Wellness Center /ID# 244933
Little Rock, Arkansas, United States, 72204
4
AHF Research Center /ID# 254795
Beverly Hills, California, United States, 90211