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

Bristol-Myers Squibb3 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Advanced Melanoma Hepatitis B Hepatitis C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Taipei, Taiwan

Outcomes

Primary Outcomes

Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load

Time frame: During 6months after enrollment

Data from ClinicalTrials.gov

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