Hepatitis C, Chronic | Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
Hepatitis C, Chronic research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Hepatitis C, Chronic
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Miravirsen every other week dosingMiravirsen 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 dosingMiravirsen 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.
Start Date: June 2013
Completed Date: January 2015
Phase: Phase 2
Primary Outcome: The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Secondary Outcome: The proportion of subjects with undetectable HCV RNA levels at end of treatment.
Study sponsors, principal investigator, and references
Principal Investigator: Michael Hodges, MD
Lead Sponsor: Santaris Pharma A/S