Clincosm LogoSign in Get a demo

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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02452814
Collaborator
(none)
8
Enrollment
3
Locations
35.9
Actual Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    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
    Actual Study Start Date :
    May 7, 2014
    Actual Primary Completion Date :
    May 3, 2017
    Actual Study Completion Date :
    May 3, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with adverse changes in liver ultrasound results [Up to 48 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Transplant Physicians Dallas Texas United States 75203
    2 Research Specialists of Texas Houston Texas United States 77030
    3 Fundacion de Investigacion de Diego San Juan Puerto Rico 00927

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02452814
    Other Study ID Numbers:
    • NP29710
    First Posted:
    May 25, 2015
    Last Update Posted:
    Feb 6, 2018
    Last Verified:
    Feb 1, 2018
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic

    Study Results

    No Results Posted as of Feb 6, 2018