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
Sponsored by Hoffmann-La Roche
About this trial
Last updated 8 years ago
Study ID
NP29711
Status
Completed
Type
Observational
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 9 years ago
What is this trial about?
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.
What are the participation requirements?
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
Exclusion Criteria
- Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207