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Trial record 96 of 312 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02402699
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Advanced Melanoma Hepatitis B Hepatitis C

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
Actual Study Start Date : May 23, 2015
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019


Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load [ Time Frame: During 6months after enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402699


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
Taiwan
Local Institution Recruiting
Taipei 105, Taiwan
Contact: Site 0004         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02402699     History of Changes
Other Study ID Numbers: CA184-414
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Bristol-Myers Squibb:
HBV
HBC

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
Melanoma
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections