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Hormone Therapy

Growth Hormone Therapy for Growth Hormone Deficiency

Phase 3

Recruiting

Led By Benjamin U. Nwosu, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged 5-15 years

Ability to take subcutaneous GH injections nightly

Timeline

Screening 3 weeks

Treatment Varies

Follow Up i year

Awards & highlights

Study Summary

This trial studies different doses of growth hormone therapy for children ages 5-15 with hormone deficiency. Safety, growth and potential adult height will be monitored.

Who is the study for?

This trial is for children aged 5-15 with growth hormone deficiency who are in good health or have no other major illnesses. They must be willing to follow the study rules and take nightly GH injections. Kids with GH resistance, syndromic short stature like Prader Willi or Turner syndrome, cancer, or serious heart, kidney, or liver issues can't join.Check my eligibility

What is being tested?

The study tests two different starting doses of growth hormone (Somatropin) in kids: one group gets a higher dose (0.3mg/kg/week), the other a lower dose (0.2 mg/kg/week). Their growth speed and predicted adult height will be checked every four months for a year.See study design

What are the potential side effects?

Possible side effects from Somatropin include reactions at the injection site, headaches, muscle pain, weakness, and developing antibodies that might make the treatment less effective.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 and 15 years old.

Select...

I can take nightly injections under my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ i year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~i year

This trial's timeline: 3 weeks for screening, Varies for treatment, and i year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized Growth Velocity (GV) in the first year after treatment

Secondary outcome measures

HbA1c - 4,8,12 months

IGF1- 0,4,8,12 months

IGFBP3 - 0,4,8,12 months

+2 more

Trial Design

2Treatment groups

Active Control

Group I: Arm 2: Growth hormone 0.3 mg/kg/weekActive Control1 Intervention

Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment

Group II: Arm 1: Growth hormone 0.2 mg/kg/weekActive Control1 Intervention

Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,993 Total Patients Enrolled

Benjamin U. Nwosu, MDPrincipal InvestigatorNORTHWELL HEALTH, INC.

1 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a way for me to participate in this experiment?

"This trial is seeking 50 participants, ages 5 to 15, that are diagnosed with growth disorders."

Answered by AI

Does this experiment accept older participants?

"According to the criteria for enrollment, participants must be between 5 and 15 years of age. For those outside this range, there are 18 trials available for minors and 6 studies reserved for seniors over 65."

Answered by AI

Are there any vacancies remaining in this experiment for participants?

"Per the information on clinicaltrials.gov, this trial is actively seeking patients for enrolment. The study was initially published on November 10th 2023 and underwent its most recent amendment on October 25th 2023."

Answered by AI

Has the administration determined that Arm 1: Growth hormone 0.2 mg/kg/week is safe for human use?

"There is already evidence to suggest Arm 1: Growth hormone 0.2 mg/kg/week is safe, thus this intervention earned a score of 3 in our estimation. This assessment was made as it went through Phase 3 trials with supportive clinical data validating its efficacy and safety parameters."

Answered by AI

What is the current enrollment capacity for this clinical research?

"Affirmative. On clinicaltrials.gov, it is indicated that this study commenced on November 10th 2023 and was recently updated on October 25th 2023; they are currently recruiting 50 individuals from a singular location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06103513.