Clinical Trial Results:
A phase IIa, randomized, double-blind (subject and investigator blind, sponsor open) placebo-controlled trial to evaluate the safety, tolerability and antiviral activity of oral ACH-0141625 in combination with pegylated interferon alfa-2a and ribavirin in two segments, after 28 days of dosing and, subsequently, after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1.
Summary
|
|
EudraCT number |
2010-022092-65 |
Trial protocol |
DE BE |
Global completion date |
30 Apr 2013
|
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 |
19 Aug 2016
|
First version publication date |
19 Aug 2016
|
Other versions |
|
Summary report(s) |
ACH625-003 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.