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

Phase 2

Completed

• Conditions: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1; Hepatitis C Viral Infection
• Interventions: Drug: Faldaprevir; Drug: TD-6450; Drug: Ribavirin

• Registration Number: NCT02716428
• Lead Sponsor: Trek Therapeutics, PBC

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Study Start: 2016-05
• Status Verified: 2017-01
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Chronic genotype 1b 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 (kilopascals)
  • A non-invasive test measuring liver scarring (FibroSure®) score ≤ 0.48 and AST (aspartate aminotransferase):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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 2	TD-6450	12 weeks of Faldaprevir plus TD-6450
Cohort 1	TD-6450	12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
Cohort 1	Ribavirin	12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
Cohort 2	Faldaprevir	12 weeks of Faldaprevir plus TD-6450
Cohort 1	Faldaprevir	12 weeks of Faldaprevir plus 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 with and without ribavirin in Genotype 1b Hepatitis C infected adults	Post Treatment Week 12

Secondary Outcome Measures

Name	Time	Method
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 with and without ribavirin)	Post Treatment Weeks 2 to 8
Safety as determined by the incidence of serious adverse events, Grade 3 or 4 adverse events and laboratory abnormalities, and discontinuations due to adverse events	Randomization through End of Study, up to 24 weeks

Trial Locations

Locations (6)

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

Bach and Godofsky Infectious Diseases; 🇺🇸 Bradenton, Florida, United States

Auckland Clinical Studies; 🇳🇿 Auckland, New Zealand

Dunedin Hospital; 🇳🇿 Dunedin, New Zealand

Waikato Hospital; 🇳🇿 Waikato, New Zealand

Gastro One; 🇺🇸 Germantown, Tennessee, United States