Status:

RECRUITING

Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)

Lead Sponsor:

Xiaoping Luo

Conditions:

Childhood Short Stature

Eligibility:

All Genders

2+ years

Brief Summary

Short stature is a relatively common pediatric condition, referring to individuals whose height is more than 2 (-2 SD) standard deviations below the average height of a similar age, gender, and ethnic...

Eligibility Criteria

Inclusion

  • Children aged 2 years and older with various causes of short stature.
  • Height below the 3rd percentile (-1.88 SD) compared to the height of normal, healthy children of the same age and gender.
  • Belonging to one of the following indications: GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, or other causes of short stature.
  • Note: In this study, the inclusion criteria for the PWS cohort do not impose restrictions on height and age at the start of treatment.

Exclusion

  • Patients with fully closed growth plates.
  • Patients with signs of potential tumor progression or those already diagnosed with tumors.
  • Allergic reactions to growth hormone or its adjuvants.
  • Patients who have received any growth hormone treatment other than the investigational drug in the six months prior to screening.
  • Any other circumstances deemed unsuitable for study inclusion by the investigator.

Key Trial Info

Start Date :

March 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

10000 Patients enrolled

Trial Details

Trial ID

NCT06110910

Start Date

March 1 2023

End Date

December 31 2027

Last Update

November 5 2024

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

TongjiHospital

Wuhan, Hubei, China, 430030

Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS) | DecenTrialz