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

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT06103513
Phase
PHASE3
Status
Recruiting
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Conditions

  • Growth
  • Growth Disorders
  • Growth Failure
  • Growth Hormone Treatment

Eligibility Criteria

Sex
ALL
Age
5 Years - 15 Years
Healthy Volunteers
Accepted

Interventions

  • Somatropin — DRUG
    The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.

Study Details

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 Dates

First listed
Oct 26, 2023
Start date
Dec 10, 2023
Status verified
Oct 2026
Primary completion
Jan 5, 2028
Completion
Jan 5, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Annualized Growth Velocity (GV) in the first year after treatment [ Time Frame: I year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell HealthNew YorkNew York11042
Neetu Vashistha, MA
[email protected]
516-472-3631
Ishrat Ghani
[email protected]
516-472-3631
Benjamin Nwosu, MD (PRINCIPAL_INVESTIGATOR)
Naama Pollack-Schreiber, MD (SUB_INVESTIGATOR)

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Northwell Health· New York, NY

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