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

Idiopathic Growth Hormone Deficiency Clinical Trial

Official title:
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Randomised, Open-label, Parallel-group, Multi-centre Trial (FE 999905 CS07) in Which the Efficacy and Safety of 12 Months' Treatment With One Daily Dose of ZOMACTON Were Compared to One Daily Dose of GENOTROPIN

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacodynamics Study

Related Conditions & MeSH terms

Dwarfism, Pituitary
Endocrine System Diseases
Idiopathic Growth Hormone Deficiency

Clinical Trial Details

NCT number	NCT02173821
Study type	Interventional
Source	Ferring Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	October 2014
Completion date	April 2015

View Details

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01419249` - First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study	Phase 4
	Completed	`NCT03223025` - Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency	Phase 3