The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEG-rhGH, GnRHa.
- Who it may be relevant to
- Registry conditions: Short Stature. Basic parameters: 1 year — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug PEG-rhGH
1= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH - Drug GnRHa
1. pubertal children of short stature without GnRHa treatment 2. pubertal children of short stature with GnRHa treatment
Primary outcome measures
- height growth rate [Time frame: 2 years]
Secondary outcome measures (2)
- Sexual development status [Time frame: two years]
- IGF-1 [Time frame: two years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06768411 · SAHoWMU-CR2024-06-223