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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04326374
Other study ID # CT301-CN
Secondary ID CTR20200399
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 30, 2019
Est. completion date April 2022

Study information

Verified date March 2020
Source Visen Pharmaceuticals (Shanghai) Co., Ltd.
Contact Lisa Chen, MD
Phone +86-02152999605
Email lisa.chen@visenpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).


Description:

Not Provided


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
TransCon hGH
Once weekly subcutaneous injection
daily hGH
Once daily subcutaneous injection

Locations

Country Name City State
China Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Visen Pharmaceuticals (Shanghai) Co., Ltd. Ascendis Pharma A/S

Country where clinical trial is conducted

China, 

Outcome

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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