Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
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|ClinicalTrials.gov Identifier: NCT01727934|
Recruitment Status : Unknown
Verified January 2014 by Santaris Pharma A/S.
Recruitment status was: Active, not recruiting
First Posted : November 16, 2012
Last Update Posted : January 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Miravirsen sodium||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||April 2014|
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
- The proportion of subjects with sustained virological response 24 weeks after the end of therapy. [ Time Frame: 36 weeks ]
- 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 ]
- Viral resistance analysis at baseline and throughout the study. [ Time Frame: 60 weeks ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727934
|Fundacion de Investigation de Diego|
|San Juan, Puerto Rico, 00927|
|Principal Investigator:||Maribel Rodriguez-Torres, MD||Fundacion de Investgacion de Diego|