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

Trek Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Viral Infection; Hepatitis C (HCV); Hepatitis C Genotype 4; Chronic Hepatitis C

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02593162

TRK-450-0201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Exclusion criteria

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Faldaprevir

Drug: Ribavirin

Drug: TD-6450

Group 2

Experimental group

Description:

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

Treatment:

Drug: Faldaprevir

Drug: Ribavirin

Drug: TD-6450