Evaluation of the Clinical Efficacy and Safety of BriTurn... | NCT06246331

Studies
Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection

NCT06246331

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Unknown status

Last Update Posted

Feb 7, 2024Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Reversal of Neuromuscular Blockade

Interventions

Not provided

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 20, 2023

First Submission Date that Met QC Criteria

Feb 4, 2024

First Posted Date

Feb 7, 2024Actual

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

Feb 4, 2024

Last Update Posted Date

Feb 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

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

This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

Detailed Description

Efficacy: Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
Safety: whether bradycardia and resulting cardiac arrest occur or whether bronchospasm occurs

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

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)	Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%) after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes	after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults over 19 years of age
Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium

Exclusion Criteria:

Pregnant women or nursing women
Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection

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

Adults aged 19 years or older

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sangseok Lee	Contact	+82-2-950-1989		s2248@paik.ac.kr

Overall Officials

Name	Affiliation	Role
Sangseok Lee	Inje University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University Sanggye Paik Hospital	Recruiting	Seoul		01757	South Korea