← Back to Search

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

ELEVATE 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.Check my eligibility

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.See study design

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.

ELEVATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups

ELEVATE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GenSci004Experimental Treatment1 Intervention

Group II: GenotropinActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Changchun GeneScience Pharmaceutical Co., Ltd.Lead Sponsor

57 Previous Clinical Trials

16,216 Total Patients Enrolled

Bradley MillerStudy ChairUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 25 and above eligible participants in this trial?

"This clinical trial has an age range of 3 to 12 years old, so any participants must fit within these parameters."

Answered by AI

Is it still possible to join this experiment?

"Clinicaltrials.gov indicates that the recruitment for this trial, which was initially uploaded on December 1st 2023 and last modified on September 7th 2023, has concluded. However, there are two other medical studies currently seeking participants."

Answered by AI

Has GenSci004 been given the green light by the Food and Drug Administration?

"Our assessment of the safety profile for GenSci004 is a 3, as it has reached Phase 3 clinical trials. This indicates there is existing evidence indicating efficacy and multiple rounds demonstrating its risk-free nature."

Answered by AI

What criteria must be met to qualify for participation in this clinical experiment?

"To qualify for participation, children aged 3 to 12 with growth hormone deficiency must apply. This medical trial is seeking 162 individuals in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007417.

All > Growth Hormone Deficiency