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

Phase 2

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Miravirsen every other week dosing	Miravirsen	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.
Miravirsen every other week dosing	Telaprevir	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.
Miravirsen monthly dosing	Ribavirin	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.
Miravirsen every other week dosing	Ribavirin	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.
Miravirsen monthly dosing	Miravirsen	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.
Miravirsen monthly dosing	Telaprevir	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.

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.	42 weeks

Secondary Outcome Measures

Name	Time	Method
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

Locations (3): Research Specialists of Texas
🇺🇸
Houston, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸
Dallas, Texas, United States
Fundacion de Investigacion de Diego
🇵🇷
San Juan, Puerto Rico

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