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Accepting PatientsPhase 3 (Comparison)NCT06103513

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

Growth Disorders, Growth Failure

Phase:Phase 3 (Comparison)
Status:Accepting Patients
Age:5 - 15
Gender:All
Locations:1 site

What This Study Is About

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.

Who Can Participate

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 Cannot Join 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.
Key Requirements
  • Able to provide informed consent
  • Age 5-15 years
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)

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.

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

Northwell Health — New York, New York

Contact

Contact

Namma Pollack-Schreiber, MD

Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

Apply to This Trial

Your information will be sent to the study coordinator for review.