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

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ClinicalTrials.gov Identifier: NCT06007417
Recruitment Status : Not yet recruiting
First Posted : August 23, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Changchun GeneScience Pharmaceutical Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
GHD Drug: GenSci004 Drug: Genotropin Phase 3

Detailed Description:
The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: GenSci004 Drug: GenSci004
GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
Active Comparator: Genotropin Drug: Genotropin
Genotropin


Outcome Measures
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Primary Outcome Measures :
  1. Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups [ Time Frame: 52 weeks ]
    Measured in centimeter per year (cm/year)


Secondary Outcome Measures :
  1. Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups [ Time Frame: 104 weeks ]
    Measured in centimeter per year (cm/year)


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Prepubertal children with GHD in Tanner Stage 1
  2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
  3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
  4. Growth hormone stimulation tests: ≤10 ng/mL
  5. 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)
  6. Normal 46 XX karyotype for girls.
  7. Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
  8. Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant

Exclusion Criteria:

  1. BA≥CA
  2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
  3. Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
  4. Participation in any other trial of an investigational agent within 3 months prior to Screening.
  5. Any reason per investigator's discretion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06007417


Contacts
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Contact: Peng Duan +86-431-85195060 info@gensci-china.com

Locations
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United States, Texas
Cook Childrens
Fort Worth, Texas, United States, 76104
Contact: Maria Gomez         
Principal Investigator: Paul Thornton, MD         
Sponsors and Collaborators
Changchun GeneScience Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Bradley Miller University of Minnesota
More Information
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Responsible Party: Changchun GeneScience Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT06007417    
Other Study ID Numbers: GenSci004-301
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Changchun GeneScience Pharmaceutical Co., Ltd.:
GHD
growth hormone deficiency