Clinical Trial Results:
Antiviral effect, safety and pharmacokinetics of BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve and treatment-experienced patients for 24 weeks as combination therapy with pegylated interferon-α 2a and ribavirin (doubleblinded, randomised, placebo-controlled, Phase II).
Summary
|
|
EudraCT number |
2008-003538-11 |
Trial protocol |
DE ES FR NL PT GB AT CZ |
Global completion date |
28 Nov 2011
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
10 Mar 2016
|
First version publication date |
10 Mar 2016
|
Other versions |
|
Summary report(s) |
Trial Synopsis |
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.