A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
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ClinicalTrials.gov Identifier: NCT00377182 |
Recruitment Status :
Completed
First Posted : September 18, 2006
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic | Drug: Copegus Drug: PEGASYS Drug: RO5024048 1500mg Drug: RO5024048 3000mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1 |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: PEGASYS with COPEGUS |
Drug: Copegus
1000/1200mg po daily for 4 weeks Drug: PEGASYS 180 micrograms sc weekly for 4 weeks |
Experimental: RO5024048 1500mg in combination with PEGASYS |
Drug: PEGASYS
180 micrograms sc weekly for 4 weeks Drug: RO5024048 1500mg 1500mg po bid for 4 weeks |
Experimental: RO5024048 3000mg in combination with PEGASYS |
Drug: PEGASYS
180 micrograms sc weekly for 4 weeks Drug: RO5024048 3000mg 3000mg po bid for 4 weeks |
Experimental: RO5024048 in combination with PEGASYS and COPEGUS |
Drug: Copegus
1000/1200mg po daily for 4 weeks Drug: PEGASYS 180 micrograms sc weekly for 4 weeks Drug: RO5024048 1500mg 1500mg po bid for 4 weeks |
- Adverse events (AEs) and laboratory parameters. [ Time Frame: Week 4, 8 and Week 72 ]
- Plasma concentration of HCV polymerase inhibitor [ Time Frame: Week 4 and 8 ]
- Antiviral activity [ Time Frame: Week 4, 8 and Week 72 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients, 18-65 years of age;
- CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
- chronic liver disease consistent with CHC.
Exclusion Criteria:
- infection with any HCV genotype other than genotype 1;
- previous treatment for CHC;
- medical condition associated with chronic liver disease other than CHC;
- HIV, Hepatitis A, Hepatitis B infection.

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): NCT00377182
United States, California | |
La Jolla, California, United States, 92037-1030 | |
Long Beach, California, United States, 90822 | |
Sacramento, California, United States, 95817 | |
San Diego, California, United States, 92103-8465 | |
San Diego, California, United States, 92154 | |
San Francisco, California, United States, 94115 | |
United States, Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Bradenton, Florida, United States, 34209 | |
Gainesville, Florida, United States, 32610-0214 | |
United States, Illinois | |
Chicago, Illinois, United States, 60637 | |
United States, Michigan | |
Novi, Michigan, United States, 48377 | |
United States, New York | |
Manhasset, New York, United States, 11030 | |
New York, New York, United States, 10029 | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States, 27599-7584 | |
United States, Texas | |
Dallas, Texas, United States, 75203 | |
Fort Sam Houston, Texas, United States, 78234-3879 | |
United States, Virginia | |
Richmond, Virginia, United States, 23249 | |
Puerto Rico | |
Santurce, Puerto Rico, 00909 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00377182 |
Other Study ID Numbers: |
PV18369 |
First Posted: | September 18, 2006 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents |