Evaluating the long-term effects of growth hormone treatment in children with short stature in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the long-term safety and efficacy of polyethylene glycol recombinant human growth hormone (PEG-rhGH) and recombinant human growth hormone (rhGH) in treating Chinese children diagnosed with short stature. The study will include approximately 10,000 patients, divided into retrospective and prospective cohorts, over a total duration of 16 years. It will focus on children aged 2 years and older who fall below the third percentile in height due to various medical conditions. The study will gather data from multiple centers to provide a comprehensive evaluation of treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Children aged 2 years and older with various causes of short stature.
2. Height below the 3rd percentile (-1.88 SD) compared to the height of normal, healthy children of the same age and gender.
3. 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 Criteria:

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

Where it's running

• TongjiHospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: xiaoping Luo, doctor — Tongji Hospital
• Study coordinator: xiaoping Luo, doctor
• Email: xpluo@tjh.tjmu.edu.cn
• Phone: 13387522645

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Assessing Growth in Children with Short Stature

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• Multidisciplinary evaluation and whole-genome testing for children with unexplained short stature

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.