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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

Status unknown Phase 4 Last updated 14 June 2017
What this trial tests

Phase 4 trial testing PEG-somatropin in Growth Hormone Deficiency in 600 participants. Status unknown.

Timeline
1 January 2015
Primary endpoint
1 June 2017

Quick facts

Lead sponsorChangchun GeneScience Pharmaceutical Co., Ltd.
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment600
Start date1 January 2015
Primary completion1 June 2017
Sites24 locations across China

Drugs / interventions tested

Conditions studied

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.

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):

  1. 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
  2. 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
  3. 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:

Other trials of PEG-somatropin

Trials testing the same drug.

Other recruiting trials for Growth Hormone Deficiency

Currently open trials in the same condition.

Other Changchun GeneScience Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

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