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NCT01495468
Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial
Phase 3 trial testing PEG-somatropin in Growth Hormone Deficiency in 343 participants. Completed in 1 March 2008.
1 January 2008
Quick facts
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 343 |
| Start date | 1 March 2007 |
| Primary completion | 1 January 2008 |
| Estimated completion | 1 March 2008 |
| Sites | 6 locations across China |
Drugs / interventions tested
- PEG-somatropin — full drug profile →
Conditions studied
- Growth Hormone Deficiency — all drugs for Growth Hormone Deficiency →
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 8 to 15, any sex, with Growth Hormone Deficiency. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
yearly growth velocity
Time frame: 6 months
growth velocity add as GV was the primary outcome measure
Sponsor's own description
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Long-acting growth hormone in the treatment of growth hormone deficiency in children: a systematic literature review and network meta-analysis.
Zhu J, Yuan K, Rana S, Jakki SL, et al · · 2024 · cited 14× · PMID 38580693 · DOI 10.1038/s41598-024-58616-4 -
Comparison between long-acting pegylated and daily recombinant human growth hormone for pediatric growth hormone deficiency a systematic review.
Zhang J, Guo S, Wang T, Chen Q. · · 2025 · cited 1× · PMID 40702077 · DOI 10.1038/s41598-025-10613-x
Verify or expand the search:
- PubMed search for NCT01495468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PEG-somatropin
Trials testing the same drug.
- NCT06024967 — A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone · Phase 3 · unknown
Other recruiting trials for Growth Hormone Deficiency
Currently open trials in the same condition.
- NCT06542809 — Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH · NA · recruiting
- NCT05681299 — Effects of GH and Lirglutide on AgRP · Phase 4 · recruiting
- NCT06455956 — Use of miRNAs in Growth Hormone Deficiency (GHD) · recruiting
Other Changchun GeneScience Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07534176 — To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . · Phase 1 · not yet recruiting
- NCT07476586 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants · Phase 1 · not yet recruiting
- NCT07491289 — GS1-144 in Participants With Hepatic Impairment and Healthy Female · Phase 1 · not yet recruiting
- NCT07537231 — A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Fe · Phase 1 · not yet recruiting
- NCT07366866 — A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults. · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01495468 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Changchun GeneScience Pharmaceutical Co., Ltd.
- Last refreshed: 27 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01495468.
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