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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

Study 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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 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

Growth hormone dose

Secondary outcome measures

Growth Velocity

Height standard deviation

Side effects data

From 2017 Phase 4 trial • 82 Patients • NCT02311894

21%

Headache

15%

Vomiting

10%

Upper respiratory tract infection

Injection site bruising

Rash

Pharyngitis streptococcal

Nasopharyngitis

Pyrexia

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

208,156 Total Patients Enrolled

Andrew Dauber, MDPrincipal InvestigatorChildren's National Research Institute

2 Previous Clinical Trials

11 Total Patients Enrolled

Frequently Asked Questions

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

Has Somatropin been granted official sanction by the FDA?

"After carefully evaluating the available data, our experts at Power have assigned a score of 2 to Somatropin in terms of safety. As it is currently still an ongoing Phase 2 trial, there is some evidence backing its security but no proof yet for efficacy."

Answered by AI

Could those seeking treatment still join this research initiative?

"Per the information available on clinicaltrials.gov, this medical study is no longer recruiting patients after being first posted on August 26th 2022 and last updated a few days later. However, there are currently 9 other trials with open enrollment opportunities for potential participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Growth Hormone in a Patient With a Dominant-Negative GHR Mutation

2022. "Growth Hormone in a Patient With a Dominant-Negative GHR Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05382637.