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Coronado, California 92118


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02593162


Primary Contact:

Principal Investigator
Tarek Hassanein, MD
Southern California Research Center


Backup Contact:

N/A


Location Contact:

Coronado, California 92118
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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