Status:
UNKNOWN
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
Lead Sponsor:
Visen Pharmaceuticals (Shanghai) Co., Ltd.
Collaborating Sponsors:
Ascendis Pharma A/S
Conditions:
Growth Hormone Deficiency
Endocrine System Diseases
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing o...
Detailed Description
Not Provided
Eligibility Criteria
Inclusion
- Prepubertal children with GHD in Tanner stage 1, aged of 3 years and below 17 years;
- 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
- Children with a body weight below 12 kg；
- 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.
Key Trial Info
Start Date :
December 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04326374
Start Date
December 30 2019
End Date
April 1 2022
Last Update
March 30 2020
Active Locations (1)
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1
Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, Hubei, China, 430030