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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02593162
Other study ID # TRK-450-0201
Secondary ID
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
Health authority
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

Study Design


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
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