Trial | NCT02593162  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
Study Started
Oct 31
2015
Primary Completion
Dec 31
2016
Study Completion
Dec 31
2016
Last Update
Jan 30
2017
Estimate

Drug Faldaprevir

  • Other names: BI 201335

Drug TD-6450

Drug Ribavirin

  • Other names: Ribasphere®

Group 1 Experimental

12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin

Group 2 Experimental

12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin

Criteria 

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
No Results Posted