A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
NCT ID: NCT07260500
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2025-11-11
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEG-rhGH dose 1 weekly
Jintrolong® dose 1, subcutaneous injection, once every week for 26 weeks.
PEG-rhGH Injection
Jintrolong® 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..
PEG-rhGH dose 2 weekly
Jintrolong® dose 2, subcutaneous injection, once every week for 26 weeks
PEG-rhGH Injection
Jintrolong® 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..
Daily hGH (active control)
Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks.
hGH Injection
Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.
Interventions
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PEG-rhGH Injection
Jintrolong® 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
Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Bone age on X-ray is no more than 1 year ahead of real age.
* Never taken growth hormone, IGF-1, or any ghrelin-like medicine before.
* Child and parent/guardian are willing to sign the consent form and follow the study visits.
Exclusion Criteria
* Growth-hormone deficiency.
* Any chromosome/genetic/syndrome cause of short stature.
* Other diseases that can impair growth.
* Cognitive, developmental, or psychiatric disorders that could affect assessments .
* Current or past cancer, or high familial cancer risk.
* Positive hepatitis B, hepatitis C, HIV, or active tuberculosis at screening.
* Abnormal liver or kidney blood tests.
* Pre-diabetes or diabetes at screening .
* Systemic steroids \> 28 consecutive days or \> 14 days total in the last 3 months.
* High-dose inhaled steroids \> 28 days in the last year.
* Prior use of aromatase inhibitors, GnRH analogues, sex hormones, anabolic agents, or other drugs that affect growth. 13. Unable to receive subcutaneous injections.
* Claustrophobia or inability to undergo brain MRI.
* Participated in another clinical trial with investigational treatment within 3 months.
* Any other condition that, in the investigator's opinion, makes the child unsuitable for the study.
3 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GenSci031-202
Identifier Type: -
Identifier Source: org_study_id
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