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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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

RO5024048

danoprevir

peginterferon alfa-2a [Pegasys]

ribavirin

ritonavir

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Combination without RO5024048

Combination with RO5024048

Arm Description

Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients

RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients

Outcomes

Primary Outcome Measures

Safety: Incidence of adverse events

Pharmacokinetics (PK): Area under the concentration-time curve (AUC)

Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test

Secondary Outcome Measures

Emergence of viral resistance: HCV RNA gene sequence variations

Virologic response: HCV RNA levels

Full Information

NCT ID

NCT01483742

First Posted

November 30, 2011

Last Updated

July 28, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01483742

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination without RO5024048

Arm Type

Experimental

Arm Description

Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients

Arm Title

Combination with RO5024048

Arm Type

Experimental

Arm Description

RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients

Intervention Type

Drug

Intervention Name(s)

RO5024048

Intervention Description

1000 mg orally bid, 24 weeks

Intervention Type

Drug

Intervention Name(s)

danoprevir

Intervention Description

100 mg orally bid, 24 weeks

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

180 mcg weekly, 24 weeks

Intervention Type

Drug

Intervention Name(s)

ribavirin

Intervention Description

1000-1200 mg/kg/day orally in two divided doses, 24 weeks

Intervention Type

Drug

Intervention Name(s)

ritonavir

Intervention Description

100 mg orally bid, 24 weeks

Primary Outcome Measure Information:

Title

Safety: Incidence of adverse events

Time Frame

48 weeks

Title

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

Title

Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Emergence of viral resistance: HCV RNA gene sequence variations

Time Frame

From baseline to Week 48

Title

Virologic response: HCV RNA levels

Time Frame

approximately 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

City

Coronado

State/Province

California

ZIP/Postal Code

92118

Country

United States

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202-2689

Country

United States

City

Hillsborough

State/Province

New Jersey

ZIP/Postal Code

08844

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

City

Fitzroy

State/Province

South Australia

ZIP/Postal Code

3065

Country

Australia

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2C7

Country

Canada

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

City

Montpellier

ZIP/Postal Code

34094

Country

France

City

Auckland

ZIP/Postal Code

1142

Country

New Zealand

City

Christchurch

ZIP/Postal Code

8140

Country

New Zealand

City

Chorzów

ZIP/Postal Code

41-500

Country

Poland

City

Myslowice

ZIP/Postal Code

41-400

Country

Poland

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

City

Wrocław

ZIP/Postal Code

51-149

Country

Poland

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

12. IPD Sharing Statement

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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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