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A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Copegus
Danoprevir
Danoprevir
Danoprevir
Pegasys
Ritonavir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • Adults patients, >/=18 years of age
  • Chronic Hepatitis C, Genotype 1 and 4
  • HCV RNA >/=50,000 IU/mL
  • treatment-naive

Exclusion Criteria:

  • Patients with cirrhosis or incomplete/transition to cirrhosis
  • Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks

Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks

Outcomes

Primary Outcome Measures

Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)

Secondary Outcome Measures

Safety: Incidence of adverse events
Evaluation of relapse rate
Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)
Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)
Evaluation of virological breakthrough (viral load rebound) rate
Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)

Full Information

First Posted
October 7, 2010
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01220947
Brief Title
A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (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 randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

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
Randomized
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Arm Title
Group B
Arm Type
Experimental
Arm Description
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Arm Title
Group C
Arm Type
Experimental
Arm Description
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Arm Title
Group D
Arm Type
Experimental
Arm Description
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Arm Title
Group E
Arm Type
Active Comparator
Arm Description
Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Copegus
Intervention Description
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Danoprevir
Intervention Description
Danoprevir 50 mg BID
Intervention Type
Drug
Intervention Name(s)
Danoprevir
Intervention Description
Danoprevir 100 mg BID
Intervention Type
Drug
Intervention Name(s)
Danoprevir
Intervention Description
Danoprevir 200 mg BID
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
Pegasys 180 microgram sc qw
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
Ritonavir 100 mg
Primary Outcome Measure Information:
Title
Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time Frame
24 weeks after end of treatment
Secondary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
from baseline up to 72 weeks
Title
Evaluation of relapse rate
Time Frame
up to 24 weeks after end of treatment
Title
Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)
Time Frame
from baseline up to 72 weeks
Title
Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time Frame
From baseline up to 72 weeks
Title
Evaluation of virological breakthrough (viral load rebound) rate
Time Frame
up to 72 weeks
Title
Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)
Time Frame
up to 72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults patients, >/=18 years of age Chronic Hepatitis C, Genotype 1 and 4 HCV RNA >/=50,000 IU/mL treatment-naive Exclusion Criteria: Patients with cirrhosis or incomplete/transition to cirrhosis Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac 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
La Jolla
State/Province
California
ZIP/Postal Code
92037-1030
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7584
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Salvador
State/Province
BA
ZIP/Postal Code
40210-341
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14049-900
Country
Brazil
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2S2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
City
Clichy
ZIP/Postal Code
92118
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Berlin
ZIP/Postal Code
10969
Country
Germany
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08915
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
City
London
ZIP/Postal Code
W1 1TF
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

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