Clinical Trial Results:
Estudio multicéntrico aleatorizado, controlado con placebo, para evaluar la eficacia y la seguridad de eltrombopag en sujetos trombocitopénicos infectados por el virus de la hepatitis C (VHC) que, por lo demás, resulten elegibles para iniciar tratamiento antiviral (peginterferón alfa-2a más ribavirina)
Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a plus ribavirin)
ENABLE 1 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE)
Summary
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EudraCT number |
2006-004946-17 |
Trial protocol |
ES FR BE NL IT CZ GB SK DE |
Global completion date |
31 Mar 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 |
08 Jul 2016
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First version publication date |
08 Jul 2016
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Other versions |
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Summary report(s) |
103922-FDAAA-Result-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.