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NCT01504802 · ClinicalTrials.gov registry record

Pharmacodynamics of CNP During Growth Hormone Treatment

A clinical trial, sponsored by Nemours Children's Clinic.

Completed
Registry status
22
Enrollment target

NCT01504802: Completed study, sponsored by Nemours Children's Clinic.

NCT01504802 is a clinical trial that has completed, run by Nemours Children's Clinic. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01504802 has completed, sponsored by Nemours Children's Clinic.

COMPLETED
Registry status
22 participants
Enrollment target

Study Summary

It is now widespread practice to treat children with short stature with growth hormone. However, how an individual child will respond to growth hormone treatment is unpredictable and highly variable. Some children will not respond to growth hormone treatment at all. Currently, the only way to determine how well growth hormone therapy is working is to wait until they have been treated for six months and to compare the pre-treatment growth velocity with the growth velocity on treatment. It would be helpful to have a blood test that could be done shortly after starting growth hormone that could predict whether how well a child is responding to treatment. Such a blood test would allow endocrinologists to adjust the growth hormone dose (or possibly stop it altogether, if it is not working) long before the six months it currently takes. C-type natriuretic peptide (CNP) and its partner amino-terminal propeptide of CNP (NTproCNP) are proteins that play a critical role in regulating growth. The investigators have previously shown that blood levels of these proteins increase in children being treated with growth hormone. The investigators believe that a blood test for these proteins will be useful in predicting a child's response to growth hormone treatment. The purpose of this study is to determine when after starting growth hormone, the blood levels of CNP and NTproCNP start to increase.

Primary Outcome

NTproCNP will be modeled over time for each individual subject and the time it reaches 95% of its peak value determined. This value will then be averaged for the cohort.

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2010-11
Est. Completion 2014-09
Nemours Children's Clinic

108 total trials

What the finished NCT01504802 record still lists

NCT01504802 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01504802 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01504802 about?

NCT01504802 is a clinical study titled "Pharmacodynamics of CNP During Growth Hormone Treatment". It is now widespread practice to treat children with short stature with growth hormone. However, how an individual child will respond to growth hormone treatment is unpredictable and highly variable. Some children will not respond to growth hormone treatment at all. Currently, the only way to determ...

What is the current status of trial NCT01504802?

This trial is currently completed. The enrollment target is 22 participants. The study started on 2010-11. Estimated completion is 2014-09.

Who is sponsoring clinical trial NCT01504802?

This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01504802, the US trial registry maintained by the National Library of Medicine. NCT01504802 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.