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

NCT06768411 | Not Yet Recruiting DMC

• 1 other identifier: SAHoWMU-CR2024-06-223
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• height growth rate

  Measure the height and observe how many centimeters it grows each month

  2 years

Secondary Outcomes (2)

• Sexual development status

  two years

• IGF-1

  two years

Other Outcomes (1)

• bone age

  2 years

Study Arms (2)

prepubertal children of short stature

OTHER

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

Drug: PEG-rhGH

pubertal children of short stature

OTHER

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

Drug: PEG-rhGH; Drug: GnRHa

Interventions

PEG-rhGH DRUG

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

Also known as: 1, 2

prepubertal children of short stature; pubertal children of short stature

GnRHa DRUG

1. pubertal children of short stature without GnRHa treatment 2. pubertal children of short stature with GnRHa treatment

pubertal children of short stature

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Known or suspected hypersensitivity reactions to the investigational product or related products;
• Presence of severe systemic diseases;
• Patients with malignant tumors;
• Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening;
• Patients unable to adhere to follow-up or receive treatment as scheduled;

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Dwarfism

Interventions

polyethylene glycol-recombinant human growth hormone

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Central Study Contacts

Xiaoou Shan

CONTACT

+86 1377779922; 2296037178@qq.com

Mengjie Yang

CONTACT

+86 159 5871 0186; 540718644@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 10, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 10, 2025

Record last verified: 2025-01