NCT02593162

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Trek Therapeutics, PBC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatitis C Viral Infection
• Chronic Hepatitis C
• Hepatitis C (HCV)
• Hepatitis C Genotype 4

Interventions

Type	Name	Description
DRUG	Faldaprevir
DRUG	TD-6450
DRUG	Ribavirin

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-10-30
• Last updated: 2017-01-30

Locations

1 site across 1 country: United States