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
1 other identifier
observational
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2013
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2017
CompletedNovember 1, 2017
October 1, 2017
3.5 years
July 23, 2015
October 30, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Incidence of adverse events
Up to 36 months
Incidence of sustained virologic response (SVR)
48 weeks after end of treatment (EOT)
Change from Baseline in HCV ribonucleic acid (RNA) level
Up to 36 months
Incidence of HCV resistance
Up to 36 months
Study Arms (1)
Study Population
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.
Eligibility Criteria
This study will enroll null responders with CHC genotype 1 virus infection who have participated in Study SPC3649-207.
You may qualify if:
- 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
You may not qualify if:
- Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Santaris Pharma A/Scollaborator
Study Sites (1)
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
Biospecimen
Blood and urine samples will be collected over a course of 7 study visits to obtain hematology, chemistry, urinalysis, coagulation, HCV RNA, and viral resistance data.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2015
First Posted
July 24, 2015
Study Start
August 2, 2013
Primary Completion
January 13, 2017
Study Completion
January 13, 2017
Last Updated
November 1, 2017
Record last verified: 2017-10