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

Condition(s) studied

Investigational drug(s) / intervention(s)

Inpegsomatropin Injection: Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly,treatment is continued until participants reach near-adult height.

Study summary

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 will enter the final-height follow-up period, during which growth and development status, medication exposure and safety will be followed up via outpatient visits. This study aims to observe the long-term safety and efficacy of the investigational product.

Eligibility

Primary outcome measure(s)

• Safety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results. — Every 13 weeks during the first year, and then every 52 weeks (up to 16 years)
  Assessments include vital signs, physical examinations, laboratory tests, and Imaging studies.

Trial sites (27)

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