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

Trek Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Viral Infection; Hepatitis C Genotype 1; Hepatitis C (HCV); Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: TD-6450; Drug: Faldaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02716428

TRK-450-0203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Cohort 1

Experimental group

Description:

12 weeks of Faldaprevir plus TD-6450 plus Ribavirin

Treatment:

Drug: Faldaprevir

Drug: TD-6450

Drug: Ribavirin

Cohort 2

Experimental group

Description:

12 weeks of Faldaprevir plus TD-6450

Treatment:

Drug: Faldaprevir

Drug: TD-6450