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

NCT02402699 | Completed

• 1 other identifier: CA184-414
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Melanoma; Hepatitis B; Hepatitis C

Keywords

HBV; HBC

Outcome Measures

Primary Outcomes (1)

• Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load

  During 6months after enrollment

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult unresectable, recurrent, or Metastatic Melanoma patients with HBV or HCV treated with at least 1 dose of Ipilimumab therapy in Taiwan

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Taipei, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 30, 2015
• Study Start: December 15, 2015
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

TW (1)