Title
Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
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
Phase
Phase 2Lead Sponsor
Santaris Pharma A/SStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Hepatitis CIntervention/Treatment
miravirsen ...Study Participants
10The 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.
Subcutaneous injection
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.
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
