A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency
ELEVATE
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)
1 other identifier
interventional
162
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedSeptember 11, 2023
September 1, 2023
1.4 years
August 9, 2023
September 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
Measured in centimeter per year (cm/year)
52 weeks
Secondary Outcomes (1)
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
104 weeks
Study Arms (2)
GenSci004
EXPERIMENTALGenotropin
ACTIVE COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cook Childrens
Fort Worth, Texas, 76104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bradley Miller
University of Minnesota
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2023
First Posted
August 23, 2023
Study Start
December 1, 2023
Primary Completion
May 1, 2025
Study Completion
August 1, 2025
Last Updated
September 11, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share