Chronic Hepatitis C Clinical Trial
Official title:
Phase 2a, Randomized, Double-Blind Study to Investigate the Safety and Efficacy of Faldaprevir in Combination With Ribavirin and TD-6450 for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 4 Hepatitis C Virus
Verified date | January 2017 |
Source | Trek Therapeutics, PBC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Southern California Research Center | Coronado | California |
Lead Sponsor | Collaborator |
---|---|
Trek Therapeutics, PBC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 |
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