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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01483742

First received: November 30, 2011

Last updated: February 23, 2015

Last verified: February 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2011

Last Updated Date

February 23, 2015

Start Date ^ICMJE

April 2012

Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety: Incidence of adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics: 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 ] [ Designated as safety issue: No ]
Antiviral activity: HCV RNA levels assessed by Roche COBAS Taqman HCV Test [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01483742 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Emergence of viral resistance: HCV RNA gene sequence variations [ Time Frame: From baseline to Week 48 ] [ Designated as safety issue: No ]
Virologic response: HCV RNA levels [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1 Treatment-naïve
Interventions:
- Drug: danoprevir
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: ribavirin
- Drug: ritonavir
Experimental: 2 Prior null responders
Interventions:
- Drug: RO5024048
- Drug: danoprevir
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: ribavirin
- Drug: ritonavir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2013

Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Australia, Canada, France, New Zealand, Poland, Slovakia

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01483742

Other Study ID Numbers ^ICMJE

NP27946, 2011-004129-28

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

February 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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