The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children

Not Applicable

Not yet recruiting

• Conditions: Short Stature
• Interventions: Drug: PEG-rhGH; Drug: GnRHa

• Registration Number: NCT06768411
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

This study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. By employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth hormone. Our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-24
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Start: 2025-01-15
• Primary Completion: 2026-12-30
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Patients with short stature or a genetic target height below 2 standard deviations;
2. Individuals who are pre-pubertal (Tanner stage I) and pubertal (Tanner stages II-IV).
3. Legal guardians consenting to participate in the study and signing informed consent forms.

Exclusion Criteria

1. Known or suspected hypersensitivity reactions to the investigational product or related products;
2. Presence of severe systemic diseases;
3. Patients with malignant tumors;
4. Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening;
5. Patients unable to adhere to follow-up or receive treatment as scheduled;
6. Other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prepubertal children of short stature	PEG-rhGH	prepubertal children of short stature with different Initial doses of PEG-rhGH
pubertal children of short stature	GnRHa	pubertal children of short stature with different Initial doses of PEG-rhGH with or without GnRHa treatment
pubertal children of short stature	PEG-rhGH	pubertal children of short stature with different Initial doses of PEG-rhGH with or without GnRHa treatment

Primary Outcome Measures

Name	Time	Method
height growth rate	2 years	Measure the height and observe how many centimeters it grows each month

Secondary Outcome Measures

Name	Time	Method
Sexual development status	two years	Evaluate Tanner staging, The Tanner Staging, also known as Sexual Maturity Rating (SMR), is a classification system that healthcare providers use to document and track the development of secondary sex characteristics of children during puberty. It's a tool that outlines the stages of puberty for children and when they're likely to occur.
IGF-1	two years	IGF-1, known as insulin-like growth factor, is utilized to evaluate the efficacy of growth hormone therapy. By measuring IGF-1 levels, doctors can determine the effectiveness of the treatment and whether the patient's growth falls within the normal range