Status:
UNKNOWN
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Lead Sponsor:
Northwell Health
Conditions:
Growth Disorders
Growth Failure
Eligibility:
All Genders
5-15 years
Phase:
PHASE3
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 re...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06103513
Start Date
December 10 2023
End Date
December 10 2025
Last Update
December 13 2023
Active Locations (1)
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1
Northwell Health
New York, New York, United States, 11042