Growth Hormone Deficiency Clinical Trial
Official title:
The Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in China
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 of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Visen Pharmaceuticals (Shanghai) Co., Ltd. | Ascendis Pharma A/S |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annualized height velocity(AHV) at Week 52 | Annualized height velocity at Week 52 for weekly TransCon hGH treatment and the daily hGH treatment groups | 52 Weeks | |
Secondary | AHV and the change from baseline over 52 weeks at each visit | AHV and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks at each visit | 52 Weeks | |
Secondary | Height SDS and the change from baseline over 52 weeks | Height SDS and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks | 52 weeks | |
Secondary | Serum IGF-1 and IGFBP-3 levels, and IGF-1 SDS, IGFBP-3 SDS, and the change from baseline over 52 weeks at each visit | Serum IGF-1 and IGFBP-3 levels, and IGF-1 SDS, IGFBP-3 SDS, and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks at each visit | 52 weeks | |
Secondary | The percentage of participants achieving IGF-1 SDS 0 to +2.0 | The normalization of IGF-1 SDS (percentage of participants achieving IGF-1 SDS 0 to +2.0 over 52 weeks for the TransCon hGH and the daily hGH treatment group | 52 weeks | |
Secondary | Incidence of Treatment-Emergent Adverse Events | 52 weeks | ||
Secondary | The plasma concentration | pharmacokinetics measure of hGH over 52 weeks in TransCon hGH group | 52 weeks |
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