A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01057667

Collaborator

(none)

168

Enrollment

Locations

Arms

Duration (Months)

6.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: RO5024048 Drug: Ribavirin [Copegus] Drug: peginterferon alfa-2a [Pegasys]	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: With RO5024048 Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily).	Drug: RO5024048 1000mg bid po, 24 weeks Drug: Ribavirin [Copegus] 1000mg or 1200mg po daily Drug: peginterferon alfa-2a [Pegasys] 180mcg sc weekly
Active Comparator: Arm B: Standard treatment Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.	Drug: Ribavirin [Copegus] 1000mg or 1200mg po daily Drug: peginterferon alfa-2a [Pegasys] 180mcg sc weekly

Arm

Intervention/Treatment

Experimental: Arm A: With RO5024048

Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily).

Drug: RO5024048

1000mg bid po, 24 weeks

Drug: Ribavirin [Copegus]

1000mg or 1200mg po daily

Drug: peginterferon alfa-2a [Pegasys]

180mcg sc weekly

Active Comparator: Arm B: Standard treatment

Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.

Drug: Ribavirin [Copegus]

1000mg or 1200mg po daily

Drug: peginterferon alfa-2a [Pegasys]

180mcg sc weekly

Outcome Measures

Primary Outcome Measures

Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test) [24 weeks after last treatment dose]

Secondary Outcome Measures

Virologic response over time [weeks 4, 12, 24, 36, 48 and 60]
Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin [week 12 and 24]
Resistance profile of RO5024048 [weeks 1-24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adult patients, 18-70 years of age
hepatitis C, genotype 1 or 4, of over 6 months duration
treatment-naïve
negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

pregnant or breast feeding females or male partners of pregnant females
previous interferon or ribavirin based therapy or investigational anti-HCV agent
systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
hepatitis A or B, or HIV infection
history or evidence of medical condition associated with chronic liver disease other than HCV

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	La Jolla	California	United States	92037-1030
2	Bradenton	Florida	United States	34209
3	Atlanta	Georgia	United States	30309
4	Honolulu	Hawaii	United States	96813
5	Honolulu	Hawaii	United States	96817
6	Chicago	Illinois	United States	60637
7	Indianapolis	Indiana	United States	46202
8	Kansas City	Kansas	United States	66160
9	Kansas City	Missouri	United States	64131
10	Lebanon	New Hampshire	United States	03756
11	Albuquerque	New Mexico	United States	87131
12	Bronx	New York	United States	10468
13	New York	New York	United States	10003
14	New York	New York	United States	10021
15	Philadelphia	Pennsylvania	United States	19104
16	Columbia	South Carolina	United States	29204
17	Nashville	Tennessee	United States	37232
18	Houston	Texas	United States	77030
19	San Antonio	Texas	United States	78234
20	Calgary	Alberta	Canada	T2N 4Z6
21	Vancouver	British Columbia	Canada	V5Z 1H2
22	Vancouver	British Columbia	Canada	V6Z 2K5
23	Winnipeg	Manitoba	Canada	R3A 1R9
24	London	Ontario	Canada	N6A 5A5
25	Ottawa	Ontario	Canada	K1H 8L6