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NCT02976675
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin
Phase 4 trial testing PEG-somatropin in Growth Hormone Deficiency in 600 participants. Status unknown.
1 June 2017
Quick facts
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 600 |
| Start date | 1 January 2015 |
| Primary completion | 1 June 2017 |
| Sites | 24 locations across China |
Drugs / interventions tested
- PEG-somatropin — full drug profile →
- 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 3 to 18, 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.
-
Ht SDSca
Time frame: Baseline, 4,12,26 weeks after initiating treatment
Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age
Sponsor's own description
To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.
Publications & conference data
3 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 -
Reduced Effectiveness and Comparable Safety in Biweekly <i>vs.</i> Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial.
Sun C, Lu B, Liu Y, Zhang Y, et al · · 2021 · cited 8× · PMID 34899612 · DOI 10.3389/fendo.2021.779365 -
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 NCT02976675
- 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 NCT02976675 (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: 14 June 2017
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