Clinical trial NCT06103513: Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Growth Disorders
Growth Failure
Growth Hormone Treatment
Growth
Keywords: Growth Hormone
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Annualized Growth Velocity (GV) in the first year after treatment
timeFrame: I year
Secondary outcomes:
measure: IGF1- 0,4,8,12 months
timeFrame: 12 Months
measure: IGFBP3 - 0,4,8,12 months
timeFrame: 12 Months
measure: HbA1c - 4,8,12 months
timeFrame: 12 Months
measure: Total T4 or Free T4 - 0,12 months
timeFrame: 12 Months
measure: TSH - 0, 12 months
timeFrame: 12 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: NORTHWELL HEALTH, INC.
name: Benjamin U. Nwosu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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