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Clinical trial

Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)

ID
Name
ACTG A5380
Description
The purpose of this study is to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks in acute hepatitis C (HCV)-infected participants, with or without HIV-1 coinfection.
Trial arms
Trial start
2019-11-15
Estimated PCD
2023-05-18
Trial end
2023-08-22
Status
Completed
Phase
Early phase I
Treatment
Glecaprevir/Pibrentasvir (G/P)
Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.
Arms:
Glecaprevir/Pibrentasvir (G/P)
Ribavirin (RBV)
Tablets containing 200 mg of ribavirin. RBV dosed according to weight-based and renal dosing tables in study protocol.
Arms:
Glecaprevir/Pibrentasvir (G/P)
Size
45
Primary endpoint
Proportion of participants with sustained virologic response at 12 weeks post-treatment (SVR12)
Week 16 (12 weeks post treatment)
Proportion of participants who experienced adverse events (AEs)
From study treatment initiation to 4 weeks after study treatment discontinuation (Week 8)
Number of participants who complete 4 weeks of treatment without discontinuation due to AEs
From study entry to Week 4
Eligibility criteria
Inclusion Criteria * Acute HCV infection (or reinfection) within 24 weeks prior to entry. * Detectable HCV RNA at the screening visit. Exclusion Criteria * Any HCV treatment during the current acute HCV infection episode. * Known preexisting cirrhosis * Acute HIV-1 infection * Presence of active or acute AIDS-defining opportunistic infections, active serious infection (other than HIV-1 or HCV), active hepatitis B virus (HBV) or active hepatitis A virus (HAV) * Chronic use of systemically administered immunosuppressive agents * History of solid organ transplantation. * History of conditions that could interfere with the absorption of the study drug. * Concurrent use of prohibited medications * Known hypersensitivity to glecaprevir or pibrentasvir, the metabolites, or parts of the formulation. * Females who are pregnant or breastfeeding * Males with pregnant female partner.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}
Updated at
2024-03-27

1 organization

2 products

2 indications

Organization
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Product
Glecaprevir + Pibrentasvir
Indication
Hepatitis C
Indication
HIV Infection
Product
Ribavirin