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

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santaris Pharma A/S
• Treatments: Interferon-alpha; Interferons; Ribavirin

Criteria

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