Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Completed
- Conditions
- HCV
- Registration Number
- NCT02452814
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Participated in Study SPC3649-205 (this would include those who completed study SPC3649-205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of HCV infection).
Exclusion Criteria
- Those unwilling to provide informed consent for participation in this study.
- Subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of Study SPC3649-205.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with adverse changes in liver ultrasound results Up to 48 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Methodist Transplant Physicians
🇺🇸Dallas, Texas, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Research Specialists of Texas
🇺🇸Houston, Texas, United States