Overview

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

Status:
Recruiting
Trial end date:
2025-12-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Northwell Health
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.