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

Ferring

Status and phase: Completed; Phase 3

Conditions: Idiopathic Growth Hormone Deficiency

Treatments: Procedure: Blood sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT02173821

2014-000627-24 (EudraCT Number)

000134

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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