Oral GS3-007a for children with growth hormone deficiency

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

The trial has two parts. Part 1 is a double-blind, randomized comparison of different doses of GS3-007a dry suspension versus placebo in children with growth hormone deficiency over 14 days to identify a safe, tolerable dose. Part 2 is open-label and compares the selected GS3-007a dose to an approved treatment over 52 weeks, followed by an extension phase of up to 156 weeks to examine long-term effects. The study includes a long-term follow-up to observe sustained safety and potential growth benefits. Eligible participants are prepubertal children aged 3 years or older with confirmed GHD who have not received growth-promoting therapy and meet specific height criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* chronological age (CA) ≥3 years at Screening
* Prepubertal girls or boys
* Height at Screening lower than the reference height for normal children of the same chronological age and sex minus 2 standard deviations (-2 SD)
* A confirmed diagnosis of growth hormone deficiency (GHD)
* Having not been treated with any growth-promoting drugs
* BA delayed by ≥6 months compared with the CA at Screening Subjects who meet all of the following criteria are eligible to enroll in the extension study (applicable for Part II extension period)
* Subjects who have completed the 52-week treatment period of phase II
* Subjects who do not permanently discontinue the investigational Medicinal Product (IMP) during the 52-week treatment period of phase II

Exclusion Criteria:

* A highly allergic constitution
* Suspected or confirmed total pituitary deficiency, including patients previously confirmed with deficiency of ≥2 pituitary hormones other than GH
* Being confirmed with other chromosomal abnormalities or growth abnormalities affecting growth
* Congenital skeletal dysplasia or serious spinal anomalies
* Cognitive hypofunction, neurodevelopmental disorders, or psychiatric/psychological disorders that, in the investigator's opinion, may interfere with evaluation of study endpoints
* Any clinically significant abnormality that may affect growth or evaluation of the IMP
* Screening magnetic resonance imaging (MRI) scan of the sellar region confirming prior or current intracranial tumor growth
* Concurrent use of any medications that may affect growth or response to growth hormone therapy
* Epiphyseal closure
* Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged
* Hepatic function indicators abnormal at Screening Patients meeting any of the following criteria may not be enrolled in this extension study (applicable for Part II extension period)
* Subjects with closed epiphyses
* Any clinically significant abnormality that may affect growth or evaluation of the IMP
* Known or suspected allergy to the IMP
* Women with positive blood human chorionic gonadotropin (hCG) at the pre-treatment visit

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Lingli Sun, bachelor
• Email: sunlingli@genscigroup.com
• Phone: +86 18006171657

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

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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.