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NCT Number: NCT02173821

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

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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Key information

Conditions

Idiopathic Growth Hormone Deficiency

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country), Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

Blood sample will be collected at a single visit

Primary outcomes

  1. Prevalence of anti-human Growth Hormone (hGH) antibodies

    Time frame: At visit 1

    Measured as percentage of patients with positive anti-hGH antibodies.

Secondary outcomes

  1. Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples

    Time frame: At visit 1

    Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples.

  2. Binding capacity levels in confirmed anti-hGH antibody positive samples

    Time frame: At visit 1

    Measured as percentage of patients with binding capacity <2 mg/L in patients with confirmed positive anti-hGH antibody samples.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2014
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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