Advanced Melanoma, Hepatitis B, Hepatitis C
Conditions
Keywords
HBV, HBC
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load | During 6months after enrollment |
Countries
Taiwan
Outcome results
None listed