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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children

Sponsor
Northwell Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT06103513
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Jun 10, 2025
Anticipated Study Completion Date :
Nov 10, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1: Growth hormone 0.2 mg/kg/week

Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment

Drug: Somatropin
The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.
Other Names:
  • Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.

    		•
    Active Comparator: Arm 2: Growth hormone 0.3 mg/kg/week

    Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment

    Drug: Somatropin
    The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.
    Other Names:
  • Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Annualized Growth Velocity (GV) in the first year after treatment [I year]

      Height (cm) at 0- month visit; height (cm) at 12-month visit

    Secondary Outcome Measures

    1. IGF1- 0,4,8,12 months [12 Months]

      IGF-1 will be collected at timepoints - 0,4,8,12 months

    2. IGFBP3 - 0,4,8,12 months [12 Months]

      IGFBP3 will be collected at timepoints - 0,4,8,12 months

    3. HbA1c - 4,8,12 months [12 Months]

      HbA1c will be collected at timepoints 4,8,12 months

    4. Total T4 or Free T4 - 0,12 months [12 Months]

      Total T4 or Free T4 will be collected at timepoints 0,12 months

    5. TSH - 0, 12 months [12 Months]

      TSH will be collected at timepoints 0, 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Provision of signed and dated informed consent form

    2. Stated willingness to comply with all study procedures and availability for the duration of the study

    3. Male or female, aged 5-15 years

    4. In good general health as evidenced by medical history or diagnosed with growth hormone deficiency

    5. Ability to take subcutaneous GH injections nightly

    Exclusion Criteria:

    Subjects will be excluded if they have GH resistance, or syndromic short stature such as Prader Willi syndrome and Turner syndrome. Patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwell Health New York New York United States 11042

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    • Principal Investigator: Benjamin U. Nwosu, MD, NORTHWELL HEALTH, INC.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Northwell Health
    ClinicalTrials.gov Identifier:
    NCT06103513
    Other Study ID Numbers:
    • 23-0027
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    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 Northwell Health
    Growth Hormone
    Additional relevant MeSH terms:
    Growth Disorders
    Failure to Thrive

    Study Results

    No Results Posted as of Oct 30, 2023