Status:
UNKNOWN
A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
GHD
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.
Detailed Description
The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with grow...
Eligibility Criteria
Inclusion
- Prepubertal children with GHD in Tanner Stage 1
- Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
- Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
- Growth hormone stimulation tests: ≤10 ng/mL
- 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)
- Normal 46 XX karyotype for girls.
- Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
- Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant
Exclusion
- BA≥CA
- Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
- Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
- Participation in any other trial of an investigational agent within 3 months prior to Screening.
- Any reason per investigator's discretion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06007417
Start Date
December 1 2023
End Date
August 1 2025
Last Update
September 11 2023
Active Locations (1)
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1
Cook Childrens
Fort Worth, Texas, United States, 76104