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

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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02173821

Enrollment

Registered

2014-06-25

Start date

2014-10-31

Completion date

2015-04-30

Last updated

2015-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Growth Hormone Deficiency

Brief 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.

Interventions

PROCEDUREBlood sampling

Blood sample will be collected at a single visit

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of anti-human Growth Hormone (hGH) antibodies	At visit 1	Measured as percentage of patients with positive anti-hGH antibodies.

Secondary

Measure	Time frame	Description
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples	At visit 1	Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples.
Binding capacity levels in confirmed anti-hGH antibody positive samples	At visit 1	Measured as percentage of patients with binding capacity \<2 mg/L in patients with confirmed positive anti-hGH antibody samples.

Countries

Hungary, India, Israel, Poland, Romania, Russia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026