A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 15
Healthy Volunteers: t
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• 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

Locations
United States
New York
Northwell Health
RECRUITING
New York
Contact Information
Primary
Jennifer Apsan, MD
japsan@northwell.edu
516-472-3750
Backup
Rashida Talib, MPH
rtalib@northwell.edu
516-472-3631
Time Frame
Start Date: 2023-12-10
Completion Date: 2025-12-10
Participants
Target number of participants: 50
Treatments
Active_comparator: Arm 1: Growth hormone 0.2 mg/kg/week
Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment
Active_comparator: Arm 2: Growth hormone 0.3 mg/kg/week
Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov

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