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

NCT ID: NCT04798690

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-08

Study Completion Date

2031-12-31

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Growth hormone

Growtropin®-II

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sung

Role: CONTACT

+82-2-920-8369

Facility Contacts

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Ho Seong Kim, M.D., Ph.D

Role: primary

+82-2-2228-2069

Other Identifiers

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DA3002_SS_OS

Identifier Type: -

Identifier Source: org_study_id

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