Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT03500562
Collaborator
(none)
3
2
10.7
1.5
0.1

Study Details

Study Description

Brief Summary

Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C
    Actual Study Start Date :
    May 8, 2018
    Actual Primary Completion Date :
    Mar 29, 2019
    Actual Study Completion Date :
    Mar 29, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    HCV participant population in China

    Outcome Measures

    Primary Outcome Measures

    1. Number of adverse events (AEs) [Approximately 72 weeks]

    2. Number of serious adverse events (SAEs) [Approximately 72 weeks]

    Secondary Outcome Measures

    1. Number of participants who discontinue therapy due to an AE [Approximately 72 weeks]

    2. Effectiveness of daclatasvir DCV-based therapy [Approximately 72 weeks]

      As measured by Sustained virologic response 12 weeks after the end of treatment (SVR12) Achieved SVR12: Hepatitis C virus (HCV) RNA below the lower limit of quantification (LLOQ)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participants 18 years of age and older

    • Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label

    Exclusion Criteria:
    • Participants under the age of 18

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Beijing Beijing China 100054
    2 Local Institution Guangzhou Guangdong China 510515

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03500562
    Other Study ID Numbers:
    • AI444-396
    First Posted:
    Apr 18, 2018
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2021