Weekly Growth Hormone for Growth Hormone Deficiency
(ELEVATE Trial)

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My height is significantly shorter than average for my age and sex.

My genetic test shows I have a normal female chromosome pattern.

My child has been on stable hormone replacement for other brain-related hormone issues for over 3 months.

+5 more

Exclusion Criteria

I do not have major health issues or reasons I can't take human growth hormone.

Bone age greater than or equal to chronological age

I have previously used growth hormone or IGF 1 therapy.

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: GenSci004Experimental Treatment1 Intervention

Group II: GenotropinActive Control1 Intervention