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NCT02452814 Clinical Trial

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

HCV Clinical Trial

Official title:
Long-term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02452814
Other study ID # NP29710
Secondary ID
Status Completed
Phase N/A
First received May 11, 2015
Last updated February 5, 2018
Start date May 7, 2014
Est. completion date May 3, 2017

Study information
Verified date February 2018
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date May 3, 2017
Est. primary completion date May 3, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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).

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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Fundacion de Investigacion de Diego San Juan
United States Methodist Transplant Physicians Dallas Texas
United States Research Specialists of Texas Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with adverse changes in liver ultrasound results Up to 48 months
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