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

Second Affiliated Hospital of Wenzhou Medical University

Status: Not yet enrolling

Conditions: Short Stature

Treatments: Drug: GnRHa; Drug: PEG-rhGH

Study type: Interventional

Funder types: Other

Identifiers

NCT06768411

SAHoWMU-CR2024-06-223

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

prepubertal children of short stature

Other group

Description:

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

Treatment:

Drug: PEG-rhGH

pubertal children of short stature

Other group

Description:

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

Treatment:

Drug: PEG-rhGH

Drug: GnRHa