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

January 11, 2022 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei 105, Taiwan
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult unresectable, recurrent, or Metastatic Melanoma patients with HBV or HCV treated with at least 1 dose of Ipilimumab therapy in Taiwan

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load
Time Frame: During 6months after enrollment
During 6months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2015

Primary Completion (Actual)

March 23, 2017

Study Completion (Actual)

March 23, 2017

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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