Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C

Study Overview
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Brief Summary
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The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.

Official Title
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A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Miravirsen sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic hepatitis C HCV genotype 1 BMI 18-38 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: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miravirsen sodium<br>Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg. | Drug: Miravirsen sodium<br>* Subcutaneous injection<br>* Other names: SPC3649;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with sustained virological response 24 weeks after the end of therapy. |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy. |  | 60 weeks | 
| The proportion of subjects with undetectable HCV RNA levels at the end of treatment. |  | 12 weeks | 
| Change in HCV RNA levels from baseline throughout the study. |  | 60 weeks | 
| The proportion of subjects who experience virological failure throughout the study. |  | 60 weeks | 
| Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis). |  | 60 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antisense, miR-122 antagonist, host factor, Chronic hepatitis C, Hepatitis C