This trial is active, not recruiting.

Condition chronic hepatitis c
Sponsor Hoffmann-La Roche
Collaborator Santaris Pharma A/S
Start date August 2013
End date November 2016
Trial size 10 participants
Trial identifier NCT02508090, NP29711


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Participants who previously received 12 weeks of miravirsen monotherapy in Study SPC3649-207 will complete up to 36 months of safety and efficacy follow-up without investigational treatment.

Primary Outcomes

Incidence of adverse events
time frame: Up to 36 months
Incidence of sustained virologic response (SVR)
time frame: 48 weeks after end of treatment (EOT)
Change from Baseline in HCV ribonucleic acid (RNA) level
time frame: Up to 36 months
Incidence of HCV resistance
time frame: Up to 36 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.