Recruiting
Phase 3

Growth Hormone

Sponsor:

Northwell Health

Code:

NCT06103513

Conditions

Growth Disorders

Growth Failure

Growth Hormone Treatment

Growth

Eligibility Criteria

Sex: All

Age: 5 - 15

Healthy Volunteers: Accepted

Interventions

Somatropin

Study Details

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 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.

Conditions

Growth Disorders

Growth Failure

Growth Hormone Treatment

Growth

Study ID

NCT06103513

Start date

Dec 10, 2023

Status verified date

Oct, 2023

Completion date

Dec 10, 2025

Anticipated

Primary completion date

Jun 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 15

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Somatropin

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jennifer Apsan, MD

516-472-3750japsan@northwell.edu

Rashida Talib, MPH

516-472-3631rtalib@northwell.edu

Locations

Northwell Health

Recruiting

New York, New York, United States, 11042

Contacts

Rashida Talib, MPH

516-472-3631rtalib@northwell.edu

Nessa Wardak

516-472-3631nwardak@northwell.edu

Principal Investigator:

Benjamin Nwosu, MD

More Information

Sponsor

Northwell Health

Last update posted

Dec 13, 2023

Last verified

Oct, 2023

Keywords

  • Growth Hormone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-12-13.