A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature

  • STATUS
    Recruiting
  • End date
    Jun 21, 2026
  • participants needed
    360
  • sponsor
    GeneScience Pharmaceuticals Co., Ltd.
Updated on 21 January 2021
growth hormone
somatropin
igf-i
somatotropin

Summary

After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.

Details
Condition Dwarfism, Idiopathic Short Stature, Severe Short Stature, short stature
Treatment PEG-somatropin
Clinical Study IdentifierNCT03255694
SponsorGeneScience Pharmaceuticals Co., Ltd.
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All subjects who have completed the first stage (52 weeks) of Phase II clinical trial (including negative controls) with completed follow-up records may be enrolled in the extension period study
Before the extension period study, the investigator shall fully inform the subjects and their guardians of all the information about the extension period study, including detailed follow-up procedure, treatment plan, laboratory examination items during follow-ups and possible benefits and risks. The extension period study shall only be initiated after the subjects and their guardians are well informed, and agree to cooperate and complete the treatment, follow-ups and examinations during the study, and sign the written informed consent

Exclusion Criteria

Subjects who have taken the following medications within 2 months before entering the extension period study
Aromatase inhibitors (which include but are not limited to Lelrozol and Anastrozole), with continuous medication 1 month
Gonadotropin releasing hormone analogues (which include but are not limited to Triptorelin, Leuprorelin and Goserelin),, with continuous medication 1 month
Sex steroids (which include but are not limited to any type of estrogen, progestin and androgen) , with continuous medication 1 month
Protein anabolic drugs (which include but are not limited to Oxandrolone, Danazol and Strombafort), with continuous medication 1 month
Glucocorticoids via oral/intravenous administration for more than 1 month
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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