CompletedPhase 3

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

Hungary, India, Israel23 participantsStarted 2014-10

Plain-language summary

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.

Who can participate

Age range2 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion Criteria: * There are no pre-defined exclusion criteria in this study

What they're measuring

Prevalence of anti-human Growth Hormone (hGH) antibodies

Timeframe: At visit 1

Trial details

NCT IDNCT02173821

SponsorFerring Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04

View on ClinicalTrials.gov More Idiopathic Growth Hormone Deficiency trials