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)

Completed · Phase 3

Conditions studied: Hepatitis C Virus (HCV)

In brief

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.

Key facts

Study ID: NCT04903626
Run by: AbbVie
People needed: 286
Starts: 2021-08-24
Expected to finish: 2024-09-17
Last updated by the study team: 2025-04-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Participants with prior treatment, including interferon for this HCV infection.
History of liver decompensation.

Where it is running

The Institute for Liver Health /ID# 228427 — Peoria, Arizona, United States
Liver Wellness Center /ID# 244933 — Little Rock, Arkansas, United States
AHF Research Center /ID# 254795 — Beverly Hills, California, United States
Velocity Clinical Research Chula Vista /ID# 238352 — Chula Vista, California, United States
AHF Healthcare Center- Hollywood /ID# 254794 — Los Angeles, California, United States
TLC Clinical Research Inc /ID# 232334 — Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 230814 — Sacramento, California, United States
Angels Clinical Research Institute /ID# 234090 — Doral, Florida, United States
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814 — Fort Lauderdale, Florida, United States
Midway Immunology and Research Center /ID# 229194 — Ft. Pierce, Florida, United States
Midland Research Group, Inc /ID# 231885 — Oakland Park, Florida, United States
Orlando Immunology Center /ID# 229839 — Orlando, Florida, United States
Tampa General Hospital /ID# 228930 — Tampa, Florida, United States
Duplicate_Triple O Research Institute /ID# 229928 — West Palm Beach, Florida, United States
Florida Medical Clinic /ID# 233489 — Zephyrhills, Florida, United States
Emory Midtown Infectious Disease Clinic /ID# 229927 — Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics /ID# 226934 — Iowa City, Iowa, United States
Duplicate_University of Kentucky Chandler Medical Center /ID# 231588 — Lexington, Kentucky, United States
University of Louisville Hospital /ID# 232139 — Louisville, Kentucky, United States
Mercy Medical Center /ID# 226937 — Baltimore, Maryland, United States
Johns Hopkins Hospital /ID# 230694 — Baltimore, Maryland, United States
Henry Ford Hospital /ID# 226932 — Detroit, Michigan, United States
University of Mississippi Medical Center /ID# 232620 — Jackson, Mississippi, United States
Las Vegas Research Center /ID# 255631 — Las Vegas, Nevada, United States
Arizona Health Research /ID# 233558 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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