A Study (Phase 1b/2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD)
NCT ID: NCT07264595
Last Updated: 2025-12-04
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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NOT_YET_RECRUITING
PHASE1/PHASE2
88 participants
INTERVENTIONAL
2025-12-31
2030-11-30
Brief Summary
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In the second part, participants will be randomly assigned to receive either the selected dose of GS3-007a or another approved treatment for 52 weeks. This part is open-label, so everyone will know which treatment is being given. After that, all participants may continue taking GS3-007a for another 156 weeks in an extension phase to study long-term effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Dose Level 1~ Dose Level 4
dose level 1、dose level 2、dose level 3、dose level 4
GS3-007a dry suspension
GS3-007a
Placebo for GS3-007a dry suspension
Placebo for GS3-007a dry suspension
Cohort 1~ Cohort 3
GS3-007a low dose , GS3-007a high dose , rhGH 0.033mg/kg
GS3-007a dry suspension
GS3-007a
rhGH injection
rhGH injection
GS3-007a cohort
GS3-007a optimal dose
GS3-007a dry suspension
GS3-007a
Interventions
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GS3-007a dry suspension
GS3-007a
Placebo for GS3-007a dry suspension
Placebo for GS3-007a dry suspension
rhGH injection
rhGH injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prepubertal girls or boys
* Height at Screening lower than the reference height for normal children of the same chronological age and sex minus 2 standard deviations (-2 SD)
* A confirmed diagnosis of growth hormone deficiency (GHD)
* Having not been treated with any growth-promoting drugs
* BA delayed by ≥6 months compared with the CA at Screening Subjects who meet all of the following criteria are eligible to enroll in the extension study (applicable for Part II extension period)
* Subjects who have completed the 52-week treatment period of phase II
* Subjects who do not permanently discontinue the investigational Medicinal Product (IMP) during the 52-week treatment period of phase II
Exclusion Criteria
* Suspected or confirmed total pituitary deficiency, including patients previously confirmed with deficiency of ≥2 pituitary hormones other than GH
* Being confirmed with other chromosomal abnormalities or growth abnormalities affecting growth
* Congenital skeletal dysplasia or serious spinal anomalies
* Cognitive hypofunction, neurodevelopmental disorders, or psychiatric/psychological disorders that, in the investigator's opinion, may interfere with evaluation of study endpoints
* Any clinically significant abnormality that may affect growth or evaluation of the IMP
* Screening magnetic resonance imaging (MRI) scan of the sellar region confirming prior or current intracranial tumor growth
* Concurrent use of any medications that may affect growth or response to growth hormone therapy
* Epiphyseal closure
* Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged
* Hepatic function indicators abnormal at Screening Patients meeting any of the following criteria may not be enrolled in this extension study (applicable for Part II extension period)
* Subjects with closed epiphyses
* Any clinically significant abnormality that may affect growth or evaluation of the IMP
* Known or suspected allergy to the IMP
* Women with positive blood human chorionic gonadotropin (hCG) at the pre-treatment visit
3 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Other Identifiers
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GenSci073-201
Identifier Type: -
Identifier Source: org_study_id
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