A Study of Combination Therapy With PEGASYS (Peginterferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00623428
First received: February 18, 2008
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do not achieve a rapid viral response at week 4 will enter the study between treatment week 6 and 8, and will receive study medication. Those who have an early virological response at week 12, and are still taking medication at week 24, will then be randomized to one of 2 study groups. Group 1 will stop treatment at this point and will have a 48 week post-treatment observation period, and Group 2 will stay on medication for a further 24 weeks, followed by a 24 week post-treatment observation period. The anticipated time on study treatment is 6-12 months, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a [Pegasys] Drug: Copegus |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- SVR [ Time Frame: 24 weeks post-treatment (week 48 for Group 1, and week 72 for Group 2). ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of patients with non-detectable HCV-RNA [ Time Frame: End of treatment (week 24 for Group 1 and week 48 for Group 2) ] [ Designated as safety issue: No ]
- Percentage of patients with >=2 log10 drop in HCV-RNA [ Time Frame: Treatment week 12 ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 233 |
| Study Start Date: | April 2008 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks (18 weeks on study)
Drug: Copegus
800-1200mg po daily for 24 weeks (18 on study)
|
| Active Comparator: 2 |
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks (42 on study)
Drug: Copegus
800-1200mg po daily for 48 weeks (42 on study)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- serological evidence of chronic hepatitis C (CHC);
- CHC genotype 2 or 3;
- receiving PEGASYS + Copegus according to local standard of care and no RVR;
- compensated liver disease.
Exclusion Criteria:
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
- coinfection with hepatitis A or B, or HIV;
- history or other evidence of decompensated liver disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623428
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| La Jolla, California, United States, 92037-1030 | |
| Lancaster, California, United States, 93534 | |
| Long Beach, California, United States, 90822 | |
| Los Angeles, California, United States, 90048 | |
| Los Angeles, California, United States, 90057 | |
| Sacramento, California, United States, 95816 | |
| Sacramento, California, United States, 95817 | |
| San Diego, California, United States, 92103-8465 | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32256 | |
| Orlando, Florida, United States, 32803 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30308 | |
| Marietta, Georgia, United States, 30060 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Louisiana | |
| Baton Rouge, Louisiana, United States, 70890 | |
| Opelousas, Louisiana, United States, 70520 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Mississippi | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| St Louis, Missouri, United States, 63104 | |
| St Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Egg Harbour Township, New Jersey, United States, 08234 | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| New York, New York, United States, 10016 | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Asheville, North Carolina, United States, 28801 | |
| Chapel Hill, North Carolina, United States, 27599-7080 | |
| Winston-salem, North Carolina, United States, 27103 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73112-4481 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Fort Sam Houston, Texas, United States, 78234-3879 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Fairfax, Virginia, United States, 22031 | |
| Richmond, Virginia, United States, 23249 | |
| Australia | |
| Darlinghurst, Australia, 2010 | |
| Fremantle, Australia, 6160 | |
| Melbourne, Australia, 3186 | |
| Nedlands, Australia, 6009 | |
| Sydney, Australia, 2139 | |
| Austria | |
| Graz, Austria, 8036 | |
| Innsbruck, Austria, 6020 | |
| Linz, Austria, 4010 | |
| Oberndorf, Austria, 5110 | |
| Wien, Austria, 1160 | |
| Wien, Austria, 1090 | |
| Belgium | |
| Antwerpen, Belgium, 2650 | |
| Bruxelles, Belgium, 1000 | |
| Bruxelles, Belgium, 1020 | |
| Bruxelles, Belgium, 1070 | |
| Gent, Belgium, 9000 | |
| Kortrijk, Belgium, 8500 | |
| Liege, Belgium, 4000 | |
| Brazil | |
| Brasilia, Brazil, 70335-000 | |
| Campinas, Brazil, 13012-970 | |
| Campinas, Brazil, 13081-970 | |
| Porto Alegre, Brazil, 90020-090 | |
| Porto Alegre, Brazil, 90035-003 | |
| Ribeirao Preto, Brazil, 14049-900 | |
| Rio de Janeiro, Brazil, 20020-022 | |
| Santo Andre, Brazil, 09060-650 | |
| Sao Luis, Brazil, 78048-790 | |
| Sao Paulo, Brazil, 04040-003 | |
| Sorocaba, Brazil, 18047-600 | |
| Vitoria, Brazil, 29043-260 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V6Z 2K5 | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Mississauga, Ontario, Canada, L5M 4N4 | |
| Germany | |
| Berlin, Germany, 10969 | |
| Berlin, Germany, 13353 | |
| Bonn, Germany, 53127 | |
| Düsseldorf, Germany, 40237 | |
| Düsseldorf, Germany, 40225 | |
| Frankfurt Am Main, Germany, 60590 | |
| Freiburg, Germany, 79106 | |
| Giessen, Germany, 35392 | |
| Hamburg, Germany, 20099 | |
| Heidelberg, Germany, 69120 | |
| Jena, Germany, 07747 | |
| Kiel, Germany, 24105 | |
| Köln, Germany, 50937 | |
| Mainz, Germany, 55101 | |
| München, Germany, 81675 | |
| Offenburg, Germany, 77654 | |
| Tübingen, Germany, 72076 | |
| ULM, Germany, 89081 | |
| Mexico | |
| Guadalajara, Mexico, 44670 | |
| Guadalajara, Mexico, 44160 | |
| Mexicali, Mexico, 21000 | |
| Mexico City, Mexico, 14050 | |
| Mexico Df, Mexico, 11649 | |
| Puebla, Mexico, 72560 | |
| Puerto Rico | |
| Santurce, Puerto Rico, 00909 | |
| Switzerland | |
| Lausanne, Switzerland, 1005 | |
| Lugano, Switzerland, 6903 | |
| St. Gallen, Switzerland, 9007 | |
| Zürich, Switzerland, 8091 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00623428 History of Changes |
| Other Study ID Numbers: | MV21371, 2007-004993-15 |
| Study First Received: | February 18, 2008 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013