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

Phase 3

Completed

• Conditions: Idiopathic Growth Hormone Deficiency

• Registration Number: NCT02173821
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Study Start: 2014-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

Seth GSMC & KEM Hospital (there may be other sites in this country); 🇮🇳 Maharashtra, India

Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country); 🇷🇴 Timisoara, Romania

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

The Chaim Sheba Medical Center (there may be other sites in this country); 🇮🇱 Ramat Gan, Israel

Uniwersyteckie Centrum Kliniczne (there may be other sites in this country); 🇵🇱 Gdansk, Poland

Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country); 🇺🇦 Kiev, Ukraine

Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country); 🇷🇺 Moscow, Russian Federation