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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Faldaprevir
* Drug: TD-6450
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin | Drug: Faldaprevir<br> <br> * Other names: BI 201335;Drug: TD-6450<br> <br> Drug: Ribavirin<br> <br> * Other names: Ribasphere®;|
| Experimental: Group 2<br>12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin | Drug: Faldaprevir<br> <br> * Other names: BI 201335;Drug: TD-6450<br> <br> Drug: Ribavirin<br> <br> * Other names: Ribasphere®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |