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

NCT04798690 | Recruiting

• 1 other identifier: DA3002_SS_OS
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• Change of annualized height velocity

  Up to 2 years after epiphyseal closure

• The difference between target height and final height

  Up to 2 years after epiphyseal closure

• Changes in Height SDS

  Up to 2 years after epiphyseal closure

• Changes in skeletal maturity

  Up to 2 years after epiphyseal closure

• Changes in IGF-1

  Up to 2 years after epiphyseal closure

Study Arms (1)

Growth hormone

Growtropin®-II

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Short stature by GHD or ISS or TS or SGA

You may qualify if:

• 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

You may not qualify if:

• Children with Epiphyseal closure

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary; Turner Syndrome

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders

Central Study Contacts

Sung

CONTACT

+82-2-920-8369; jhsung@donga.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 15, 2021
• Study Start: February 8, 2021
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

KR (1)