drugset / Trial / NCT01727934

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

NCT01727934

Phase 2 Unknown 10 enrolled Santaris Pharma A/S
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-11
Primary completion
2014-01
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Miravirsen Antisense oligonucleotide 5 mg/kg Subcutaneous