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Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02727933
Collaborator
(none)
1,941
Enrollment
1
Location
56
Actual Duration (Months)
34.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1941 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
    Actual Study Start Date :
    Nov 3, 2015
    Actual Primary Completion Date :
    Jul 5, 2020
    Actual Study Completion Date :
    Jul 5, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities [6 months to 5 years]

    Secondary Outcome Measures

    1. Incidence proportion of AEs leading to discontinuation of study therapy [6 months to 5 years]

    2. Incidence rate of AEs leading to discontinuation of study therapy [6 months to 5 years]

    3. Timing of laboratory abnormalities by toxicity grade [6 months to 5 years]

    4. Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected [4 Weeks to 24 Weeks]

    5. The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL) [24 Weeks to 36 Weeks]

    Eligibility Criteria

    Criteria

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

    • Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients

    • Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.

    Exclusion Criteria:

    • Off-label use of Daklinza and Sunvepra

    • Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Seoul Korea, Republic of

    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:
    NCT02727933
    Other Study ID Numbers:
    • AI444-335
    First Posted:
    Apr 5, 2016
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    Hepatitis C

    Study Results

    No Results Posted as of Jan 21, 2022