Hepatitis C Clinical Trial
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
Verified date | November 2014 |
Source | Santaris Pharma A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Participated in study SPC3649-207 Exclusion Criteria: - Received investigational drug therapy after discontinuation, termination, or successful completion of study SPC3649-207 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Fundacion de Investigation de Diego | San Juan |
Lead Sponsor | Collaborator |
---|---|
Santaris Pharma A/S |
Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Viral resistance analysis through end of study. | The miR-122 seed sites in HCV RNA from subjects following viral breakthrough or relapse will be subjected to genotypic sequence analysis. | 36 months | No |
Primary | 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). | 36 months | Yes | |
Secondary | Change in HCV RNA level from baseline through end of study. | 36 months | No |
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