Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Completed

• Conditions: HCV

• Registration Number: NCT02452814
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-07
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-25
• Primary Completion: 2017-05-03
• Study Completion: 2017-05-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Participated in Study SPC3649-205 (this would include those who completed study SPC3649-205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of HCV infection).

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Exclusion Criteria

• Those unwilling to provide informed consent for participation in this study.
• Subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of Study SPC3649-205.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with adverse changes in liver ultrasound results	Up to 48 months

Trial Locations

Locations (3)

Methodist Transplant Physicians; 🇺🇸 Dallas, Texas, United States

Fundacion de Investigacion de Diego; 🇵🇷 San Juan, Puerto Rico

Research Specialists of Texas; 🇺🇸 Houston, Texas, United States