Yervoy RMP: Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
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 |
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|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
- 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
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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Age of 18 years or older on date of first dose of Ipilimumab
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Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan
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Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician
Exclusion Criteria:
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Patients who received Ipilimumab as part of a clinical trial
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Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma)
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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.- CA184-414