NCT06103513 Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
| NCT ID | NCT06103513 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Northwell Health |
| Condition | Growth Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-12-10 |
| Primary Completion | 2028-01-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2023-12-10 with a primary completion date of 2028-01-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Benjamin U. Nwosu, MD
PRINCIPAL INVESTIGATOR
NORTHWELL HEALTH, INC.
Frequently Asked Questions
Who can join the NCT06103513 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 15 Years, studying Growth Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06103513 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT06103513 currently recruiting?
Yes, NCT06103513 is actively recruiting participants. Contact the research team at NPollackschr@northwell.edu for enrollment information.
Where is the NCT06103513 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06103513 clinical trial?
NCT06103513 is sponsored by Northwell Health. The principal investigator is Benjamin U. Nwosu, MD at NORTHWELL HEALTH, INC.. The trial plans to enroll 50 participants.