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

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called weekly PEG-somatropin (GenSci004) for children who have growth hormone deficiency (GHD) and have not yet received any treatment. The goal is to see how well this new medication works compared to a daily treatment called Genotropin, which is already used for growth issues in children. The trial is open to children aged between approximately 3 and 12 years who show signs of growth failure due to GHD. To be eligible, children must be prepubertal, have a specific height that is significantly below average for their age and sex, and meet certain hormone level requirements.

If a child is chosen to participate, they will receive either the new weekly treatment or the daily medication for a set period. Parents will need to provide written consent, and the child will also need to agree to take part in the study. It's important to know that the trial is not currently recruiting participants, so it may take some time before it begins. Overall, this study aims to help improve future treatments for children with GHD by understanding how effective and safe the new medication is.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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