Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatment miravirsen sodium
Phase phase 2
Sponsor Santaris Pharma A/S
Start date November 2012
End date January 2014
Trial size 10 participants
Trial identifier NCT01727934, SPC3649-207

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg.
miravirsen sodium SPC3649
Subcutaneous injection

Primary Outcomes

Measure
The proportion of subjects with sustained virological response 24 weeks after the end of therapy.
time frame: 36 weeks

Secondary Outcomes

Measure
The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.
time frame: 60 weeks
The proportion of subjects with undetectable HCV RNA levels at the end of treatment.
time frame: 12 weeks
Change in HCV RNA levels from baseline throughout the study.
time frame: 60 weeks
The proportion of subjects who experience virological failure throughout the study.
time frame: 60 weeks
Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).
time frame: 60 weeks

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

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

Additional Information

Official title A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
Principal investigator Maribel Rodriguez-Torres, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Santaris Pharma A/S.