Status:
ACTIVE_NOT_RECRUITING
A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Tongji Hospital
The First Hospital of Jilin University
Conditions:
Dwarfism
Eligibility:
All Genders
4-9 years
Phase:
PHASE2
Brief 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 u...
Eligibility Criteria
Inclusion
- 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
- 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..
Key Trial Info
Start Date :
May 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03255694
Start Date
May 12 2017
End Date
June 1 2030
Last Update
August 15 2025
Active Locations (12)
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1
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Beijing, Beijing Municipality, China
2
Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan
Wuhan, Hubei, China
3
Hunan Children's Hospital
Changsha, Hunan, China
4
Children's Hospital of Soochow University
Naning, Jiangsu, China