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

GHD Clinical Trial

— ELEVATE  

Official title:

The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06007417
• Other study ID #: GenSci004-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2023
• Source: Changchun GeneScience Pharmaceutical Co., Ltd.
• Contact: Peng Duan
• Phone: +86-431-85195060
• Email: info[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: August 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• GHD

Intervention

Drug:
• GenSci004
GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
• Genotropin
Genotropin

Locations

Country	Name	City	State
United States	Cook Childrens	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Changchun GeneScience Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups	Measured in centimeter per year (cm/year)	52 weeks
Secondary	Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups	Measured in centimeter per year (cm/year)	104 weeks