NCT02716428

A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Trek Therapeutics, PBC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.

Detailed description

A study to evaluate the safety and effect of treatment with experimental antiviral drugs alone or in combination with ribavirin in treatment-naïve participants with genotype 1b hepatitis C infection. The study will test the safety and anti-viral activity of two regimens administered for a duration of 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 1

Interventions

Type	Name	Description
DRUG	Faldaprevir
DRUG	TD-6450
DRUG	Ribavirin

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-03-23
• Last updated: 2017-10-17

Locations

6 sites across 2 countries: United States, New Zealand