Ipilimumab 60-month Pharmacovigilance Protocol for Advanc... | NCT02402699

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

NCT02402699

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 26, 2022Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Advanced Melanoma
Hepatitis B
Hepatitis C

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2015Actual

Primary Completion Date

Mar 23, 2017Actual

Completion Date

Mar 23, 2017Actual

First Submitted Date

Mar 16, 2015

First Submission Date that Met QC Criteria

Mar 25, 2015

First Posted Date

Mar 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2022

Last Update Posted Date

Jan 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load		During 6months after enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Taipei			Taiwan

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

ID	Term
D006509	Hepatitis B
D006526	Hepatitis C