A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency
NCT ID: NCT06007417
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
162 participants
INTERVENTIONAL
2023-12-01
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GenSci004
GenSci004
GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
Genotropin
Genotropin
Genotropin
Interventions
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GenSci004
GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
Genotropin
Genotropin
Eligibility Criteria
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Inclusion Criteria
2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
4. Growth hormone stimulation tests: ≤10 ng/mL
5. Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0)
6. Normal 46 XX karyotype for girls.
7. Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
8. Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant
Exclusion Criteria
2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
3. Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
4. Participation in any other trial of an investigational agent within 3 months prior to Screening.
5. Any reason per investigator's discretion
3 Years
12 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Bradley Miller
Role: STUDY_CHAIR
University of Minnesota
Locations
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Cook Childrens
Fort Worth, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Maria Gomez
Role: primary
Other Identifiers
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GenSci004-301
Identifier Type: -
Identifier Source: org_study_id
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