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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 104 weeks
Awards & highlights
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 104 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
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
63 Previous Clinical Trials
17,047 Total Patients Enrolled
Bradley MillerStudy ChairUniversity of Minnesota
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