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A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials

RecruitingNAAges 4 Years - 13 YearsAllXiamen Amoytop Biotech Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This study is a multicenter, open-label, single-arm extension study to evaluate the safety and efficacy of long-term administration of Inpegsomatropin Injection in participants with Idiopathic Short Stature (ISS) who have completed Phase Ⅲ clinical trials. Upon completion of the Phase Ⅲ clinical study, participants may enter the extension-phase baseline assessment period after the participant and their guardian provide informed consent, based on the willingness of the participant and guardian as well as the investigator's comprehensive assessment of the benefit-risk profile for the participant's continued participation in this study. Participants who meet all inclusion criteria and do not meet any exclusion criteria will proceed to the extension-phase treatment period to receive continued treatment with Inpegsomatropin Injection. Upon completion of the treatment period, participants wil

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Inpegsomatropin Injection
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Where

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

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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