Clinical Trial Results:
A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects with Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantation
Summary
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EudraCT number |
2005-004096-37 |
Trial protocol |
IE ES GB DE IT GR |
Global completion date |
12 Apr 2011
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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 |
12 Feb 2016
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First version publication date |
12 Feb 2016
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Other versions |
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Summary report(s) |
GS-US-174-0108 FDAAA Results Summary |
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.