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

Phase 3

Recruiting

• Conditions: Growth; Growth Disorders; Growth Failure; Growth Hormone Treatment
• Interventions: Drug: Somatropin

• Registration Number: NCT06103513
• Lead Sponsor: Northwell Health

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.

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 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-26
• Study Start: 2023-12-10
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Primary Completion: 2025-06-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Growth hormone 0.3 mg/kg/week	Somatropin	Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment
Arm 1: Growth hormone 0.2 mg/kg/week	Somatropin	Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment

Primary Outcome Measures

Name	Time	Method
Annualized Growth Velocity (GV) in the first year after treatment	I year	Height (cm) at 0- month visit; height (cm) at 12-month visit

Secondary Outcome Measures

Name	Time	Method
IGFBP3 - 0,4,8,12 months	12 Months	IGFBP3 will be collected at timepoints - 0,4,8,12 months
HbA1c - 4,8,12 months	12 Months	HbA1c will be collected at timepoints 4,8,12 months
TSH - 0, 12 months	12 Months	TSH will be collected at timepoints 0, 12 months
IGF1- 0,4,8,12 months	12 Months	IGF-1 will be collected at timepoints - 0,4,8,12 months
Total T4 or Free T4 - 0,12 months	12 Months	Total T4 or Free T4 will be collected at timepoints 0,12 months

Trial Locations

Locations (1)

Northwell Health; 🇺🇸 New York, New York, United States