Idiopathic Growth Hormone Deficiency Clinical Trial
Official 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
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 17 Years |
| Eligibility |
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 |
Endpoint Classification: Pharmacodynamics Study
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country) | Budapest | |
| India | Seth GSMC & KEM Hospital (there may be other sites in this country) | Maharashtra | |
| Israel | The Chaim Sheba Medical Center (there may be other sites in this country) | Ramat Gan | |
| Poland | Uniwersyteckie Centrum Kliniczne (there may be other sites in this country) | Gdansk | |
| Romania | Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country) | Timisoara | |
| Russian Federation | Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country) | Moscow | |
| Ukraine | Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country) | Kiev |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Hungary, India, Israel, Poland, Romania, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of anti-human Growth Hormone (hGH) antibodies | Measured as percentage of patients with positive anti-hGH antibodies. | At visit 1 | No |
| Secondary | 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 | No |
| Secondary | 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. | At visit 1 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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