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

Phase 2

Completed

• Conditions: Hepatitis C Viral Infection; Chronic Hepatitis C; Hepatitis C Genotype 4; Hepatitis C (HCV)
• Interventions: Drug: Faldaprevir; Drug: TD-6450; Drug: Ribavirin

• Registration Number: NCT02593162
• Lead Sponsor: Trek Therapeutics, PBC

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Ribavirin	12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
Group 1	Ribavirin	12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
Group 2	TD-6450	12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
Group 1	TD-6450	12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
Group 1	Faldaprevir	12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
Group 2	Faldaprevir	12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Southern California Research Center; 🇺🇸 Coronado, California, United States