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

Status unconfirmed · Phase 3

Conditions studied: Growth Disorders, Growth Failure, Growth Hormone Treatment, Growth

In brief

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.

Key facts

Study ID

NCT06103513

Run by

Northwell Health

People needed

50

Starts

2023-12-10

Expected to finish

2025-12-10

Last updated by the study team

2023-12-13

Who can join

Age: 5 and older, up to 15. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Northwell Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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