Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatments miravirsen, telaprevir, ribavirin
Phase phase 2
Sponsor Santaris Pharma A/S
Start date June 2013
End date January 2015
Trial size 20 participants
Trial identifier NCT01872936, SPC3649-205

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 6 every other week doses at 5 mg/kg in combination with telaprevir and ribavirin.
miravirsen SPC3649
telaprevir Incivek
ribavirin Copegus
(Other)
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 3 monthly doses at 7 mg/kg in combination with telaprevir and ribavirin.
miravirsen SPC3649
telaprevir Incivek
ribavirin Copegus

Primary Outcomes

Measure
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
time frame: 42 weeks

Secondary Outcomes

Measure
The proportion of subjects with undetectable HCV RNA levels at end of treatment.
time frame: 18 weeks
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
time frame: 66 Weeks
Change in HCV RNA levels from baseline throughout the study.
time frame: 66 Weeks
The proportion of subjects who experience virological failure throughout the study.
time frame: 66 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Santaris Pharma A/S.