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

Phase 2

• Conditions: Hepatitis C
• Interventions: Drug: Miravirsen sodium

• Registration Number: NCT01727934
• Lead Sponsor: Santaris Pharma A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Miravirsen sodium	Miravirsen sodium	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.

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with sustained virological response 24 weeks after the end of therapy.	36 weeks

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who experience virological failure throughout the study.	60 weeks
The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.	60 weeks
The proportion of subjects with undetectable HCV RNA levels at the end of treatment.	12 weeks
Change in HCV RNA levels from baseline throughout the study.	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).	60 weeks

Trial Locations

Locations (1)

Fundacion de Investigation de Diego; 🇵🇷 San Juan, Puerto Rico