Hepatitis C Clinical Trial
— Yervoy RMPOfficial title:
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
NCT number | NCT02402699 |
Other study ID # | CA184-414 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 15, 2015 |
Est. completion date | March 23, 2017 |
Verified date | January 2022 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | March 23, 2017 |
Est. primary completion date | March 23, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Local Institution | Taipei 105 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load | During 6months after enrollment |
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