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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trek Therapeutics, PBC
• Treatments: Antiviral Agents; Ribavirin

Criteria

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