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Alisporivir With pegIFN/RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C: Open Label
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This study is not yet open for participant recruitment.
Verified on December 2011 by Novartis
First Received on December 23, 2011. Last Updated on December 27, 2011
The purpose of this study is to evaluate the overall efficacy, and safety profile, of triple combination therapy of DEB025/pegIFN/RBV in chronic hepatitis C patients who failed prior treatment with PI.
Estimated Enrollment: 150
Study Start Date: February 2012
Criteria
Inclusion criteria:
1. HCV GT1 patients with previous PI treatment failure.
2. Timing of the PI treatment. the minimum time from the last dose of previous PI treatment to the first dose of study medication is three months.
3. Diagnosed Chronic hepatitis C virus infection
4. Infection with HCV genotype 1
Exclusion criteria:
1. Use of other investigational drugs at the time of enrollment,
2. History of hypersensitivity to any pegIFN or RBV.
3. Any null non-responders to prior pegIFN/RBV treatment,
Other protocol-defined inclusion/exclusion criteria may apply.
http://clinicaltrials.gov/ct2/show/NCT01500772?term=hepatitis+c+AND+protease+inhibitor&rank=1
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