A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
| End Date: | September 2013 |
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and
antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys
(peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added
to the combination treatment in prior null responder patients with chronic hepatitis C
genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg
orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously
weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048
1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.
antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys
(peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added
to the combination treatment in prior null responder patients with chronic hepatitis C
genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg
orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously
weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048
1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.
Inclusion Criteria:
- Adult patients, 18 to 65 years of age inclusive
- Chronic hepatitis C, genotype 1 or 4
- Cohort 1: Treatment-naïve for hepatitis C
- Cohort 2: Prior null responder to treatment with approved doses of pegylated
interferon plus ribavirin
- Liver biopsy confirming cirrhosis
- Compensated cirrhosis (Child-Pugh A)
Exclusion Criteria:
- Pregnant or lactating women or male partners of women who are pregnant
- History or presence of decompensated liver disease (ascites, hepatic encephalopathy,
hepatocellular carcinoma, or bleeding esophageal varices)
- Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin
treatment due to reasons other than null response
- History of clinically significant cardiovascular or cerebrovascular disease
We found this trial at
15
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials