Clinical Trial Results:
A double-blind, randomized, placebo-controlled, multi-centre, dose-ranging, parallel group, phase II study to assess efficacy, safety/tolerability, and pharmacokinetics of a thrombopoietin receptor agonist, SB-497115-GR, when administered as 30, 50, and 75 mg once daily for 12 weeks in subjects with chronic hepatitis C–related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin.
Summary
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EudraCT number |
2004-001469-16 |
Trial protocol |
GB DE ES |
Global completion date |
20 Oct 2006
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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 |
16 Feb 2016
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First version publication date |
13 Nov 2014
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Other versions |
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Summary report(s) |
TPL102357-Clinical-Study-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.