drugset
drugset / Trial / NCT01872936

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

NCT01872936 ↗

Phase 2 Unknown 20 enrolled Santaris Pharma A/S
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-06
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Miravirsen Antisense oligonucleotide 5 mg/kg Subcutaneous
Subject Miravirsen Antisense oligonucleotide 7 mg/kg Subcutaneous
Background Ribavirin Small molecule — —
Background Telaprevir Small molecule — —

Indications

chronic hepatitis C virus infection