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

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.

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Key information

Conditions

Advanced Melanoma Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Flaviviridae Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: During 6months after enrollment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Acronym: Yervoy RMP

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Mar 30, 2015
Registry last updated: Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed