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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Miravirsen every other week dosing
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.
Intervention: Miravirsen (Drug)
Miravirsen every other week dosing
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.
Intervention: Telaprevir (Drug)
Miravirsen every other week dosing
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.
Intervention: Ribavirin (Drug)
Miravirsen monthly dosing
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.
Intervention: Miravirsen (Drug)
Miravirsen monthly dosing
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.
Intervention: Telaprevir (Drug)
Miravirsen monthly dosing
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.
Intervention: Ribavirin (Drug)
Outcomes
Primary Outcomes
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Time Frame: 42 weeks
Secondary Outcomes
- 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)