Overview

This trial is active, not recruiting.

Conditions hepatitis c viral infection, chronic hepatitis c, hepatitis c (hcv), hepatitis c genotype 4
Treatments faldaprevir, td-6450, ribavirin
Phase phase 2
Sponsor Trek Therapeutics, PBC
Start date October 2015
End date November 2016
Trial size 16 participants
Trial identifier NCT02593162, TRK-450-0201

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
faldaprevir BI 201335
td-6450
ribavirin Ribasphere®
(Experimental)
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
faldaprevir BI 201335
td-6450
ribavirin Ribasphere®

Primary Outcomes

Measure
Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and ribavirin in Genotype 4 Hepatitis C infected adults
time frame: Post Treatment Week 12

Secondary Outcomes

Measure
Percentage of subjects with virologic response at Week 12 (HCV RNA less than lower limit of quantitation at end of therapy with Faldaprevir plus TD-6450 plus ribavirin)
time frame: Week 12
Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 plus ribavirin)
time frame: Post Treatment Weeks 2 to 8

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title 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
Principal investigator Tarek Hassanein, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Trek Therapeutics, PBC.