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

Hepatitis C Clinical Trial

— Yervoy RMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402699
• Other study ID #: CA184-414
• Status: Completed
• Start date: December 15, 2015
• Est. completion date: March 23, 2017

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Advanced Melanoma
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Melanoma

Locations

Country	Name	City	State
Taiwan	Local Institution	Taipei 105

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Taiwan, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls