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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593162
• Other study ID #: TRK-450-0201
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2015
• Last updated: January 27, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Trek Therapeutics, PBC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C (HCV)
• Hepatitis C Genotype 4
• Hepatitis C Viral Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• Faldaprevir

• TD-6450

• Ribavirin

Locations

Country	Name	City	State
United States	Southern California Research Center	Coronado	California

Sponsors (1)

Lead Sponsor	Collaborator
Trek Therapeutics, PBC

Country where clinical trial is conducted

United States, 

Outcome

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