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

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• 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 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