Clinical Trial Results:
Prospective, Multicentre, Randomised, Double-Blind, Parallel Group Study Comparing the Therapeutic Biosimilarity of Epostim (GMX) with Eprex (J&J) when given Intravenously to Patients undergoing Chronic Haemodialysis and on Maintenance Erythropoietin Treatment for Anaemia Associated with End-Stage Renal Disease (ESRD)
Summary
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EudraCT number |
2006-004929-28 |
Trial protocol |
LT |
Global completion date |
06 Oct 2010
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Nov 2022
|
First version publication date |
01 Nov 2022
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Other versions |
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Summary report(s) |
Core report for Protocol No.: GMX.RFM006 with Epostim |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.