A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-04-30

Brief Summary

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This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.

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Detailed Description

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Conditions

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Idiopathic Growth Hormone Deficiency

Interventions

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Blood sampling

Blood sample will be collected at a single visit

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Previous participation in trial FE 999905 CS07 and presence of anti-hGH antibodies at any post-dosing visit throughout the 12-month treatment period
* Signed informed consent and obtained assent according to local rules and practice
* Information on medical history, concomitant medications, and growth hormone therapy since completion of trial FE 999905 CS07

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No