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.
Age
3–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Prepubertal children with GHD in Tanner Stage 1
2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
4. Growth hormone stimulation tests: ≤10 ng/mL
5. 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)
6. Normal 46 XX karyotype for girls.
7. Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
8. Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant
You may not be if
1. BA≥CA
2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
3. Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
4. Participation in any other trial of an investigational agent within 3 months prior to Screening.
5. Any reason per investigator's discretion
Clareo Health | A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency
