Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

Study Overview
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Brief Summary
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The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.

Official Title
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Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Miravirsen
* Drug: Telaprevir
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic hepatitis C genotype 1 infection BMI 18 and 38 kg/m2 Null responder to pegylated interferon alpha and ribavirin Exclusion Criteria: Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Significant liver disease in addition to hepatitis C Decompensated liver disease medical history or current clinical features Histologic evidence of hepatic cirrhosis Concurrent clinically significant medical diagnosis (other than CHC) Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation) Clinically significant illness within 30 days preceding entry into the study Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication History of clinically significant allergic drug reactions

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Miravirsen every other week dosing<br>Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 6 every other week doses at 5 mg/kg in combination with telaprevir and ribavirin. | Drug: Miravirsen<br> <br> * Other names: Miravirsen sodium;Drug: Telaprevir<br> <br> * Other names: Incivek;Drug: Ribavirin<br> <br> * Other names: Copegus;|
| Other: Miravirsen monthly dosing<br>Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 3 monthly doses at 7 mg/kg in combination with telaprevir and ribavirin. | Drug: Miravirsen<br> <br> * Other names: Miravirsen sodium;Drug: Telaprevir<br> <br> * Other names: Incivek;Drug: Ribavirin<br> <br> * Other names: Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy. |  | 42 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with undetectable HCV RNA levels at end of treatment. |  | 18 weeks | 
| The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy. |  | 66 Weeks | 
| Change in HCV RNA levels from baseline throughout the study. |  | 66 Weeks | 
| The proportion of subjects who experience virological failure throughout the study. |  | 66 Weeks |