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Hormone Therapy
Somatropin for Growth Disorders
Phase 2
Waitlist Available
Led By Andrew Dauber, MD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be the specific subject with the specific mutation in GHR leading to high GHBP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial will give growth hormone to one patient with a genetic mutation that causes too much growth hormone binding protein. They will monitor how well the patient responds to the therapy.
Who is the study for?
This trial is specifically for a single patient who has signed consent and agreed to follow the study procedures. The patient must have a particular mutation in the GHR gene that causes high levels of GHBP, which affects growth.Check my eligibility
What is being tested?
The trial is testing escalating doses of Somatropin, a growth hormone, on this unique patient. The goal is to adjust the dosage until it raises insulin-like growth factor-1 above average and then observe how well the treatment stimulates growth.See study design
What are the potential side effects?
While specific side effects are not listed for this one-patient trial, common side effects of Somatropin may include joint pain, swelling due to fluid retention, muscle pain, and possible increased blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a mutation in the GHR gene causing high GHBP levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Growth hormone dose
Secondary outcome measures
Growth Velocity
Height standard deviation
Side effects data
From 2017 Phase 4 trial • 82 Patients • NCT0231189421%
Headache
15%
Vomiting
10%
Upper respiratory tract infection
9%
Injection site bruising
7%
Rash
7%
Pharyngitis streptococcal
6%
Nasopharyngitis
6%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Somatropin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Growth hormoneExperimental Treatment1 Intervention
The participant will receive escalating dose of growth hormone until an IGF-1 level is maintained between the mean and +2 standard deviations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatotropin
FDA approved
Find a Location
Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
214 Previous Clinical Trials
253,535 Total Patients Enrolled
Andrew Dauber, MDPrincipal InvestigatorChildren's National Research Institute
2 Previous Clinical Trials
11 Total Patients Enrolled
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