Efficacy and Safety Study of DEB025/Alisporivir Combined to Peg-IFN and Ribavirin in Chronic Hepatitis C Genotype 1 Treatment-naïve Patients
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | August 2013 |
A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFN and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve
This study will assess the safety and efficacy of Alisporivir when added to pegIFN and
Ribavirin to optimize treatment in patient infected with the Hepatitis C virus who have not
been previously treated for this condition
Ribavirin to optimize treatment in patient infected with the Hepatitis C virus who have not
been previously treated for this condition
Inclusion criteria:
- Chronic hepatitis C viral
- HCV genotype
- No previous treatment for hepatitis C infection
- Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction
or equivalent at screening, no upper limit
- Liver evaluation prior to Baseline: liver biopsy within 3 years or Fibroscan within 6
months
Exclusion criteria:
- HCV genotype different from genotype 1 or co-infection with other HCV genotype
- Co-infection with Hepatitis B or HIV
- Any other cause of relevant liver disease other than HCV
- Presence or history of hepatic decompensation
- ALT ≥ 10 times ULN, more than 1 episode of elevated bilirubin (>ULN) in past 6 months
- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
27
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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