A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection

Sponsor

Trek Therapeutics, PBC (Industry)

Overall Status

Completed

CT.gov ID

NCT02593162

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Viral Infection Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 4	Drug: Faldaprevir Drug: TD-6450 Drug: Ribavirin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin	Drug: Faldaprevir Other Names: BI 201335 Drug: TD-6450 Drug: Ribavirin Other Names: Ribasphere®
Experimental: Group 2 12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin	Drug: Faldaprevir Other Names: BI 201335 Drug: TD-6450 Drug: Ribavirin Other Names: Ribasphere®

Arm

Intervention/Treatment

Experimental: Group 1

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

Drug: Faldaprevir

Other Names:

BI 201335

Drug: TD-6450

Drug: Ribavirin

Other Names:

Ribasphere®

Experimental: Group 2

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

Drug: Faldaprevir

Other Names:

BI 201335

Drug: TD-6450

Drug: Ribavirin

Other Names:

Ribasphere®

Outcome Measures

Primary Outcome Measures

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 [Post Treatment Week 12]

Secondary Outcome Measures

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) [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) [Post Treatment Weeks 2 to 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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