A Study to Assess the Safety of Mavacamten in Korean Pati... | NCT06146660

Studies
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT06146660

Sponsor

Bristol-Myers Squibb

Status

Recruiting

Last Update Posted

Nov 6, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Obstructive Hypertrophic Cardiomyopathy

Interventions

Mavacamten

Countries

South Korea

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2024Actual

Primary Completion Date

Nov 30, 2026Estimated

Completion Date

Nov 30, 2026Estimated

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 23, 2023

First Posted Date

Nov 27, 2023Actual

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

Nov 5, 2024

Last Update Posted Date

Nov 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants receiving mavacamten for oHCM			Drug: Mavacamten

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mavacamten	Drug	According to approved product label	Participants receiving mavacamten for oHCM

Measure	Description	Time Frame
Number of participants with adverse events		Up to 12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult participants 19 years of age or older
Participants who receive mavacamten according to the approved product label
Participants who sign the informed consent form

Exclusion Criteria:

Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult participants diagnosed with symptomatic oHCM who will receive mavacamten according to the approved product label

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
BMS Study Connect Contact Center www.BMSStudyConnect.com	Contact	855-907-3286		Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.	Contact

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0001	Terminated	Seoul		06234	South Korea
Novotech Laboratory Korea Co., Ltd.

Label	URL
BMS Clinical Trial Information	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002312	Cardiomyopathy, Hypertrophic

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000605992	MYK-461

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided