Long-term Safety and Effectiveness of Growtropin®-II Trea... | NCT04798690

Studies
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

NCT04798690

Sponsor

Dong-A ST Co., Ltd.

Status

Recruiting

Last Update Posted

Apr 12, 2023Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Growth Hormone Deficiency
Idiopathic Short Stature
Turner Syndrome
Small for Gestational Age

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

Apr 2023

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

Feb 8, 2021Actual

Primary Completion Date

Dec 2031Estimated

Completion Date

Dec 2031Estimated

First Submitted Date

Feb 17, 2021

First Submission Date that Met QC Criteria

Mar 12, 2021

First Posted Date

Mar 15, 2021Actual

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

Apr 11, 2023

Last Update Posted Date

Apr 12, 2023Actual

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 evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.

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

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Label	Type	Description	Intervention Names
Growth hormone		Growtropin®-II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term safety assessed through the adverse events	Number of occurrence of treatment-related adverse events	Up to 2 years after epiphyseal closure

Secondary Outcomes

Measure	Description	Time Frame
Change of annualized height velocity	To assess the difference in change of annualized height velocity between baseline and every 6 months	Up to 2 years after epiphyseal closure
The difference between target height and final height

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)
Children who has official height record at least 6 months prior

Exclusion Criteria:

Children with Epiphyseal closure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Short stature by GHD or ISS or TS or SGA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sung	Contact	+82-2-920-8369		jhsung@donga.co.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Health System, Severance Hospital	Recruiting	Seoul	Seodaemun-gu	03722	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary
D014424	Turner Syndrome

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided