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

Last updated: December 12, 2023
Sponsor: Northwell Health
Overall Status: Active - Recruiting

Phase

3

Condition

Severe Short Stature

Treatment

Somatropin

Clinical Study ID

NCT06103513
23-0027
  • Ages 5-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for theduration of the study
  3. Male or female, aged 5-15 years
  4. In good general health as evidenced by medical history or diagnosed with growthhormone deficiency
  5. Ability to take subcutaneous GH injections nightly

Exclusion

Exclusion Criteria: Subjects will be excluded if they have GH resistance, or syndromic short stature such asPrader Willi syndrome and Turner syndrome. Patients will also be excluded if they haveactive malignancies, or systemic illnesses such as heart failure, kidney failure, or liverfailure.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Somatropin
Phase: 3
Study Start date:
December 10, 2023
Estimated Completion Date:
December 10, 2025

Study 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.

Connect with a study center

  • Northwell Health

    New York, New York 11042
    United States

    Active - Recruiting

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