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
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ClinicalTrials.gov Identifier: NCT01483742 |
Recruitment Status
:
Completed
First Posted
: December 1, 2011
Last Update Posted
: August 1, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic | Drug: RO5024048 Drug: danoprevir Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin Drug: ritonavir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination without RO5024048
Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients
|
Drug: danoprevir
100 mg orally bid, 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks
Drug: ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
Drug: ritonavir
100 mg orally bid, 24 weeks
|
Experimental: Combination with RO5024048
RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients
|
Drug: RO5024048
1000 mg orally bid, 24 weeks
Drug: danoprevir
100 mg orally bid, 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks
Drug: ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
Drug: ritonavir
100 mg orally bid, 24 weeks
|
- Safety: Incidence of adverse events [ Time Frame: 48 weeks ]
- Pharmacokinetics (PK): Area under the concentration-time curve (AUC) [ Time Frame: Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24 ]
- Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test [ Time Frame: 48 weeks ]
- Emergence of viral resistance: HCV RNA gene sequence variations [ Time Frame: From baseline to Week 48 ]
- Virologic response: HCV RNA levels [ Time Frame: approximately 1 year ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483742

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01483742 History of Changes |
Other Study ID Numbers: |
NP27946 2011-004129-28 ( EudraCT Number ) |
First Posted: | December 1, 2011 Key Record Dates |
Last Update Posted: | August 1, 2016 |
Last Verified: | July 2016 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Ribavirin Ritonavir |
Peginterferon alfa-2a Interferon-alpha Lactams Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Anti-HIV Agents Anti-Retroviral Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Immunologic Factors |