Trials / Completed
CompletedNCT02508090
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
Long-Term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2013-08-02
- Primary completion
- 2017-01-13
- Completion
- 2017-01-13
- First posted
- 2015-07-24
- Last updated
- 2017-11-01
Locations
1 site across 1 country: Puerto Rico
Source: ClinicalTrials.gov record NCT02508090. Inclusion in this directory is not an endorsement.