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Hormone Therapy

Weekly Growth Hormone for Growth Hormone Deficiency (ELEVATE Trial)

Phase 3
Waitlist Available
Research Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will measure if a weekly growth hormone treatment is as safe and effective as a daily one for children with growth issues.

Who is the study for?
This trial is for treatment-naive children with Growth Hormone Deficiency (GHD). They must have normal growth charts for their age and sex, no major medical conditions, not be on any other investigational drugs recently, and have never used growth hormone therapies before.
What is being tested?
The study compares the effectiveness and safety of a weekly dose of GenSci004 to a daily dose of Genotropin in children who haven't been treated for GHD. The goal is to see if taking GenSci004 once a week works as well as taking Genotropin every day.
What are the potential side effects?
Possible side effects include reactions at the injection site, headaches, muscle pain, weakness, and resistance to insulin. Long-term use might affect bone development. Each child's reaction can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GenSci004Experimental Treatment1 Intervention
Group II: GenotropinActive Control1 Intervention

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Who is running the clinical trial?

Changchun GeneScience Pharmaceutical Co., Ltd.Lead Sponsor
65 Previous Clinical Trials
17,948 Total Patients Enrolled
Bradley MillerStudy ChairUniversity of Minnesota
~38 spots leftby May 2025
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