Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
NCT ID: NCT04326374
Last Updated: 2020-03-30
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
150 participants
INTERVENTIONAL
2019-12-30
2022-04-30
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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TransCon hGH
TransCon hGH will be self-administered or injected by parents once weekly. The dose will be adjusted based on subject's weight.
The treatment will continue 52 weeks.
TransCon hGH
Once weekly subcutaneous injection
Daily hGH
Daily hGH will be self-administered or injected by parents once daily. The dose will be adjusted based on subject's weight.
The treatment will continue 52 weeks.
daily hGH
Once daily subcutaneous injection
Interventions
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TransCon hGH
Once weekly subcutaneous injection
daily hGH
Once daily subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Impaired HT defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS≤-2.0) according to the Chinese 2005 standard；
* Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay. Bone age (BA) at least 6 months less than the chronological age；
* 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)；
* Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is 8 years old or above).
Exclusion Criteria
* Prior exposure to recombinant hGH or IGF-1 therapy；
* Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast dye recommended) at Screening
* Children born SGA (birth weight ≤10th percentile for gestational age according to the Chinese reference)；
* Children with psychosocial dwarfism；
* Children with idiopathic short stature；
* Other causes of short stature such as coeliac disease, hypothyroidism, or rickets；
* History or presence of malignant disease; any evidence of present tumor growth;
* Subjects with diabetes mellitus；
* Closed epiphyses；
* Major medical conditions and/or presence of contraindication to hGH treatment；
* Participation in any other trial of an investigational agent within 3 months prior to Screening.
3 Years
17 Years
ALL
No
Sponsors
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Ascendis Pharma A/S
INDUSTRY
Visen Pharmaceuticals (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoping Luo, MD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoping Luo, MD
Role: primary
Other Identifiers
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CTR20200399
Identifier Type: OTHER
Identifier Source: secondary_id
CT301-CN
Identifier Type: -
Identifier Source: org_study_id
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