A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection
Phase 2a, Randomized, Double-Blind Study to Investigate the Safety and Efficacy of Faldaprevir in Combination With Ribavirin and TD-6450 for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 4 Hepatitis C Virus
Lead SponsorTrek Therapeutics, PBC
StatusCompleted No Results Posted
Indication/ConditionHepatitis C Viral Infection Hepatitis C (HCV) Hepatitis C Genotype 4 ...
Intervention/Treatmentfaldaprevir ribavirin td-6450 ...
Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with ribavirin in treatment-naïve participants with genotype 4 hepatitis C infection. The study will test the safety and effects of this alternative treatment for up to 12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.
12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
Inclusion Criteria: Chronic genotype 4 hepatitis C infection and HCV RNA ≥ 10^4 IU/mL at screening Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening Absence of cirrhosis as defined by one of the following: A liver biopsy performed within 24 calendar months of Day 1 showing absence of cirrhosis Transient elastography (FibroScan®) performed within 12 calendar months of Day 1 with a result of ≤ 12.5 kPa A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during screening Exclusion Criteria: Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2