Trials / Completed
CompletedNCT02173821
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
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Blood sampling | Blood sample will be collected at a single visit |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2014-06-25
- Last updated
- 2015-05-05
Locations
7 sites across 7 countries: Hungary, India, Israel, Poland, Romania, Russia, Ukraine
Source: ClinicalTrials.gov record NCT02173821. Inclusion in this directory is not an endorsement.