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.
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.
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;
Parallel
PEG-rhGH
Drug1= 0.2mg/kg/week Initial doses of PEG-rhGH 2=0.22mg/kg/week Initial doses of PEG-rhGH
GnRHa
Drug1. pubertal children of short stature without GnRHa treatment 2. pubertal children of short stature with GnRHa treatment
height growth rate
Measure the height and observe how many centimeters it grows each month
Sexual development status
Evaluate Tanner staging, The Tanner Staging, also known as Sexual Maturity Rating (SMR), is a classification system that healthcare providers use to document and track the development of secondary sex characteristics of children during puberty. It's a tool that outlines the stages of puberty for children and when they're likely to occur.
IGF-1
IGF-1, known as insulin-like growth factor, is utilized to evaluate the efficacy of growth hormone therapy. By measuring IGF-1 levels, doctors can determine the effectiveness of the treatment and whether the patient's growth falls within the normal range
bone age
Bone age assessment
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This trial is not recruiting at the moment. You can still explore other options:
