Long-term Inpegsomatropin Treatment for Idiopathic Short Stature: Extension of Phase III Study

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 is a multicenter, open-label, single-arm extension evaluating the safety and efficacy of long-term Inpegsomatropin Injection in participants with Idiopathic Short Stature who completed a Phase III trial. Eligible participants enter after providing informed consent and may receive ongoing treatment during the extension phase, followed by a final-height follow-up period to assess growth and development. The study includes adults and guardians in the consent process, with inclusion criteria focusing on prior trial completion and treatment compliance, and exclusion criteria addressing recent growth-promoting therapies and skeletal maturity. Primary purpose is to observe long-term safety and potential continued growth benefits in the extension period. Locations include major pediatric centers in Beijing, Changsha, and Chengdu under the lead sponsor Xiamen Amoytop Biotech Co., Ltd.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants previously enrolled in the ISS Phase III clinical study (Study Number: PEGPESEN-4-2-001) with good treatment compliance (80%-120%), for whom the investigator assesses that the benefit of continuing growth hormone therapy outweighs the risk, and who enter this extension study within 4 weeks after completion of the Phase III study.
* Legal guardians understand and provide signed informed consent. Participants aged ≥ 8 years shall also provide signed informed consent. For participants under 8 years of age who are capable of expressing assent, their assent shall be explicitly documented.

Exclusion Criteria:

* Participants have received other growth-promoting therapies other than those specified in the protocol within 2 months prior to entry into this extension study, including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc.
* Evidence of closed epiphyseal growth plates or achievement of near-adult height (defined as calculated HV \< 2 cm/year over at least 6 months, or bone age ≥ 16 years for males, bone age ≥ 14 years for females).
* Other conditions under which, in the investigator's opinion, continuation in this extension study is inappropriate.

Where it's running

• Capital Institute of Pediatrics, Beijing (SHOUER)
  Beijing, China Recruiting
• Hunan Children's Hospital
  Changsha, China Recruiting
• Chengdu Women's and Children's Central Hospital
  Chengdu, China Recruiting
• West China Second University Hospital, Sichuan University
  Chengdu, China Recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, China Recruiting
• The Third Affiliated Hospital, Sun Yat-sen University
  Guangzhou, China Recruiting

Study contacts

• Principal investigator: Xiaoping Luo, Ph.D — Tongji Hospital
• Study coordinator: Xiaoping Luo, Ph.D
• Email: xpluo@tjh.tjmu.edu.cn
• Phone: 15671671188

Similar studies

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

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• Evaluating the long-term safety and effectiveness of Growtropin®-II in children with 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.