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)
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1
TongjiHospital
Wuhan, Hubei, China, 430030