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

GeneScience Pharmaceuticals (GenSci)

Status and phase

Not yet enrolling

Phase 3

Conditions

GHD

Treatments

Drug: GenSci004

Drug: Genotropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06007417

GenSci004-301

Details and patient eligibility

About

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.

Full 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 growth failure due to GHD.

Enrollment

162 estimated patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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