A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection

Study Overview
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Brief Summary
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Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b 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 alone or in combination with ribavirin in treatment-naïve participants with genotype 1b hepatitis C infection. The study will test the safety and anti-viral activity of two regimens administered for a duration of 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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A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus

Conditions
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Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1

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 1b 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 (kilopascals) A non-invasive test measuring liver scarring (FibroSure®) score ≤ 0.48 and AST (aspartate aminotransferase):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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 with and without ribavirin in Genotype 1b Hepatitis C infected adults |  | Post Treatment Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 with and without ribavirin) |  | Post Treatment Weeks 2 to 8 | 
| Safety as determined by the incidence of serious adverse events, Grade 3 or 4 adverse events and laboratory abnormalities, and discontinuations due to adverse events |  | Randomization through End of Study, up to 24 weeks |