Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The proportion of subjects with sustained virological response 24 weeks after the end of therapy. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects with undetectable HCV RNA levels at the end of treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in HCV RNA levels from baseline throughout the study. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects who experience virological failure throughout the study. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Viral resistance analysis at baseline and throughout the study. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]The miR-122 seed sites in HCV RNA from subjects at baseline and following viral breakthrough or relapse will be subjected to genotypic sequence analysis.
- Plasma pharmacokinetics [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]Plasma PK for miravirsen levels will be determined for up to 2 hours post-dose on Day 1, up to 24 hours post-dose on Days 29 and 84, and pre-dose for all other treatment period visits. Additionally, plasma PK will be evaluated at all follow-up visits through Week 28.
- Urine pharmacokinetics [ Time Frame: Up to 24 hours post-dose on Day 29 and Day 84 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: Miravirsen sodium
Other Name: SPC3649
|Fundacion de Investigation de Diego||Recruiting|
|San Juan, Puerto Rico, 00927|
|Contact: Roberto Galarza 787-722-1248|
|Contact: Isamarie Alma 787-722-1248|
|Principal Investigator: Maribel Rodriguez-Torres, MD|
|Principal Investigator:||Maribel Rodriguez-Torres, MD||Fundacion de Investgacion de Diego|