A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
Recruiting
Phase 2
Interventional Study
Short Stature Children Born Small for Gestational Age (SGA)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 72 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
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