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

NCT ID: NCT06768411

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2027-06-01

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.

Conditions

Short Stature

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prepubertal children of short stature

prepubertal children of short stature with different Initial doses of PEG-rhGH

Group Type: OTHER

PEG-rhGH

Intervention Type: DRUG

1= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH

pubertal children of short stature

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

Group Type: OTHER

PEG-rhGH

Intervention Type: DRUG

1= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH

GnRHa

Intervention Type: DRUG

1. pubertal children of short stature without GnRHa treatment

2. pubertal children of short stature with GnRHa treatment

Interventions

PEG-rhGH

1= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH

Intervention Type: DRUG

GnRHa

1. pubertal children of short stature without GnRHa treatment

2. pubertal children of short stature with GnRHa treatment

Intervention Type: DRUG

Other Intervention Names

1; 2

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaoou Shan

Role: CONTACT

2296037178@qq.com

+86 1377779922

Mengjie Yang

Role: CONTACT

540718644@qq.com

+86 159 5871 0186

Other Identifiers

SAHoWMU-CR2024-06-223

Identifier Type: -

Identifier Source: org_study_id