This trial is active, not recruiting.

Condition hepatitis c
Treatment miravirsen
Phase phase 2
Sponsor Santaris Pharma A/S
Start date January 2014
End date January 2017
Trial size 10 participants
Trial identifier NCT02031133, SPC3649-207E


Study SPC3649-207E is designed as an extension study to the prior protocol to provide additional long-term safety and efficacy information for subjects participating in Study SPC3649-207.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Subjects who were enrolled in and received miravirsen doses in study SPC3649-207 will be observed for safety and efficacy in the 3-year long-term extension study SPC3649-207E. No study medication will be given during this extension study.

Primary Outcomes

Safety and tolerability will be assessed by evaluation of liver ultrasound, physical examinations, vital signs, and routine laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).
time frame: 36 months

Secondary Outcomes

Change in HCV RNA level from baseline through end of study.
time frame: 36 months

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

Inclusion Criteria: - Participated in study SPC3649-207 Exclusion Criteria: - Received investigational drug therapy after discontinuation, termination, or successful 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
Principal investigator Maribel Rodriguez-Torres, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Santaris Pharma A/S.