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.
Study Type
INTERVENTIONAL
Enrollment
23
Blood sample will be collected at a single visit
Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country)
Budapest, Hungary
Seth GSMC & KEM Hospital (there may be other sites in this country)
Maharashtra, India
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
Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country)
Timișoara, Romania
Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country)
Moscow, Russia
Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country)
Kiev, Ukraine
Prevalence of anti-human Growth Hormone (hGH) antibodies
Measured as percentage of patients with positive anti-hGH antibodies.
Time frame: At visit 1
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples.
Time frame: At visit 1
Binding capacity levels in confirmed anti-hGH antibody positive samples
Measured as percentage of patients with binding capacity \<2 mg/L in patients with confirmed positive anti-hGH antibody samples.
Time frame: At visit 1
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