Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
Completed
- Conditions
- Hepatitis CAdvanced MelanomaHepatitis B
- Registration Number
- NCT02402699
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load During 6months after enrollment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇨🇳Taipei 105, Taiwan