About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born full-term and "small-for-dates" - Born at 37-41 weeks (full-term). - Birth weight below the 10th percentile for that week of pregnancy and sex .
At least 3 years old on the day the parent signs the consent form.
Still prepubertal (Tanner stage I - no signs of puberty yet).
Height at the first study visit is more than 2 standard deviations below the average for his or her age and sex.
Disqualifiers
Severe allergy to growth hormone or its ingredients.
Growth-hormone deficiency.
Any chromosome/genetic/syndrome cause of short stature.
Other diseases that can impair growth.
Trial design
Parallel
Treatments tested in this trial
PEG-rhGH Injection
DrugJintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects..
hGH Injection
DrugJintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.
Treatment groups
Trial outcomes
Primary outcomes
Annual height velocity at Week 26 of treatment
Sponsors and contacts
Click on the lead sponsor to view all of their trials.