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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02031133
Other study ID # SPC3649-207E
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received January 7, 2014
Last updated November 17, 2014
Start date January 2014
Est. completion date January 2017

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Drug:
Miravirsen


Locations

Country Name City State
Puerto Rico Fundacion de Investigation de Diego San Juan

Sponsors (1)

Lead Sponsor Collaborator
Santaris Pharma A/S

Country where clinical trial is conducted

Puerto Rico, 

Outcome

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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