Actively Recruiting
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-02-17
72
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.
CONDITIONS
Official Title
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born full-term at 37 to 41 weeks gestation with birth weight below the 10th percentile for pregnancy week and sex
- At least 3 years old at the time of parent consent
- Prepubertal (Tanner stage I) with no signs of puberty
- Height more than 2 standard deviations below average for age and sex at first study visit
- Bone age no more than 1 year ahead of actual age on X-ray
- No prior use of growth hormone, IGF-1, or ghrelin-like medicines
- Subject and guardian able to voluntarily consent and cooperate with study procedures
You will not qualify if you...
- Severe allergy to growth hormone or its components
- Growth hormone deficiency
- Short stature caused by chromosome, genetic, or syndrome conditions
- Other diseases affecting growth
- Cognitive, developmental, or psychiatric disorders impacting assessments
- Current or past cancer or high family cancer risk
- Positive for hepatitis B, hepatitis C, HIV, or active tuberculosis at screening
- Abnormal liver or kidney blood tests
- Pre-diabetes or diabetes at screening
- Use of systemic steroids for more than 28 consecutive days or more than 14 days total in last 3 months
- Use of high-dose inhaled steroids for more than 28 days in last year
- Prior use of aromatase inhibitors, GnRH analogues, sex hormones, anabolic agents, or other growth-affecting drugs
- Unable to receive subcutaneous injections
- Claustrophobia or inability to undergo brain MRI
- Participation in another investigational clinical trial within last 3 months
- Any other condition making the child unsuitable for the study according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
X
Xiao Ping Luo
CONTACT
L
Ling Hou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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