A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency

Status unconfirmed · Phase 3

Conditions studied: GHD

In brief

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.

Key facts

Study ID

NCT06007417

Run by

Changchun GeneScience Pharmaceutical Co., Ltd.

People needed

162

Starts

2023-12-01

Expected to finish

2025-08-01

Last updated by the study team

2023-09-11

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cook Childrens — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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