Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin
Completed
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT02508090
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Participants from Study SPC3649-207, including those who completed the study and those who discontinued or terminated the study early for any reason, or those who opted to receive other approved therapy for the treatment of hepatitis C virus (HCV) infection
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Exclusion Criteria
- Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of HCV resistance Up to 36 months Incidence of adverse events Up to 36 months Incidence of sustained virologic response (SVR) 48 weeks after end of treatment (EOT) Change from Baseline in HCV ribonucleic acid (RNA) level Up to 36 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico