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

Completed · Phase 2

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

In brief

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.

Key facts

Study ID

NCT02593162

Run by

Trek Therapeutics, PBC

People needed

16

Starts

2015-10-01

Expected to finish

2016-12-01

Last updated by the study team

2017-01-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Southern California Research Center — Coronado, California, United States

Full record on ClinicalTrials.gov

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