Yervoy RMP: Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02402699
Collaborator
(none)
3
1
15.2
0.2

Study Details

Study Description

Brief Summary

This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
    Actual Study Start Date :
    Dec 15, 2015
    Actual Primary Completion Date :
    Mar 23, 2017
    Actual Study Completion Date :
    Mar 23, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Unresectable, recurrent or metastatic melanoma patients

    All adult unresectable, recurrent, or metastatic melanoma patients with HBV or HCV treated with at least 1 dose of ipilimumab therapy in Taiwan

    Outcome Measures

    Primary Outcome Measures

    1. Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load [During 6months after enrollment]

    Eligibility Criteria

    Criteria

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

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:
    • Age of 18 years or older on date of first dose of Ipilimumab

    • Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan

    • Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician

    Exclusion Criteria:
    • Patients who received Ipilimumab as part of a clinical trial

    • Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma)

    • Patients who are not infected with HBV or HCV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Taipei 105 Taiwan

    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:
    NCT02402699
    Other Study ID Numbers:
    • CA184-414
    First Posted:
    Mar 30, 2015
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Bristol-Myers Squibb
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022