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

Launched by SECOND AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to use a special growth hormone called PEG-rhGH to help children who are shorter than average, a condition known as short stature. Researchers want to find out how different doses of this growth hormone can help children grow better while keeping them safe. The goal is to give doctors better guidance on how to treat their young patients so that they can reach their full height potential.

To participate in this study, children must be between the ages of 1 and 16 and be either prepubertal (not yet gone through puberty) or in the early stages of puberty. Parents or guardians will need to give their consent for their child to take part in the study. However, children with certain health issues, such as severe diseases or allergies to the study medication, will not be eligible. This trial is not yet recruiting participants, but it aims to provide important insights that could help many children grow and develop more successfully.

Gender

ALL

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.