Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | August 2010 |
| End Date: | May 2013 |
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment
The study is to investigate whether HCV GT1 patients with a history of non-response/relapse
to PegIFN + RBV benefit from treatment with triple therapy of DEB025 plus Peg-IFN and
ribavirin compared to triple treatment with placebo matching DEB025 plus Peg-IFN and
ribavirin
to PegIFN + RBV benefit from treatment with triple therapy of DEB025 plus Peg-IFN and
ribavirin compared to triple treatment with placebo matching DEB025 plus Peg-IFN and
ribavirin
Inclusion criteria:
Chronic hepatitis C G1 viral infection; Plasma HCV RNA level lower limit ≥ 1,000 IU/ml
assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening, no
upper limit; HCV genotype 1; Previous non-responders/relapsers to PegIFN + RBV after
treatment for at least 12 weeks.
Exclusion criteria:
Treatment with any anti-HCV drug (whether approved or investigational) within 3 months
prior to screening; Women of child-bearing potential (WOCBP), defined as all women
physiologically capable of becoming pregnant, UNLESS they are using a highly effective
contraception; Any other cause of relevant liver disease other than HCV; Other
protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
17
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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