Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 4
Conditions
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.
Interventions
Sponsors
Trek Therapeutics, PBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed