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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000627-24 | EudraCT Number |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood sample will be collected at a single visit |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of anti-human Growth Hormone (hGH) antibodies | Measured as percentage of patients with positive anti-hGH antibodies. | At visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At visit 1 |
| Binding capacity levels in confirmed anti-hGH antibody positive samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country) | Budapest | Hungary | ||||
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Measured as percentage of patients with binding capacity <2 mg/L in patients with confirmed positive anti-hGH antibody samples. |
| At visit 1 |
| 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 |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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