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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00623428 |
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 (40KD) [PEGASYS] Drug: peginterferon alfa-2a [PEGASYS] Drug: Copegus |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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. |
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | August 2011 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 24 weeks (18 weeks on study)
Drug: Copegus
800-1200mg po daily for 24 weeks (18 on study)
|
| 2: Active Comparator |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference Study ID Number: MV21371 | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study Locations| United States, Alabama | |
| Active, not recruiting | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Active, not recruiting | |
| La Jolla, California, United States, 92037-1030 | |
| Active, not recruiting | |
| Lancaster, California, United States, 93534 | |
| Terminated | |
| Sacramento, California, United States, 95817 | |
| Terminated | |
| Long Beach, California, United States, 90822 | |
| Active, not recruiting | |
| San Diego, California, United States, 92103-8465 | |
| Terminated | |
| Torrance, California, United States, 90505 | |
| Terminated | |
| Los Angeles, California, United States, 90057 | |
| Active, not recruiting | |
| Sacramento, California, United States, 95816 | |
| Active, not recruiting | |
| Los Angeles, California, United States, 90048 | |
| United States, Colorado | |
| Terminated | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Terminated | |
| Jacksonville, Florida, United States, 32256 | |
| Terminated | |
| Orlando, Florida, United States, 32803 | |
| United States, Georgia | |
| Active, not recruiting | |
| Atlanta, Georgia, United States, 30308 | |
| Active, not recruiting | |
| Marietta, Georgia, United States, 30060 | |
| United States, Hawaii | |
| Active, not recruiting | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Louisiana | |
| Terminated | |
| Opelousas, Louisiana, United States, 70520 | |
| Terminated | |
| Baton Rouge, Louisiana, United States, 70890 | |
| United States, Massachusetts | |
| Terminated | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Mississippi | |
| Active, not recruiting | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| Terminated | |
| St Louis, Missouri, United States, 63104 | |
| Terminated | |
| St Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Terminated | |
| Egg Harbour Township, New Jersey, United States, 08234 | |
| Terminated | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| Terminated | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Terminated | |
| Syracuse, New York, United States, 13210 | |
| Terminated | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Active, not recruiting | |
| Asheville, North Carolina, United States, 28801 | |
| Terminated | |
| Winston-salem, North Carolina, United States, 27103 | |
| Terminated | |
| Chapel Hill, North Carolina, United States, 27599-7080 | |
| United States, Oklahoma | |
| Terminated | |
| Oklahoma City, Oklahoma, United States, 73112-4481 | |
| United States, Oregon | |
| Active, not recruiting | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Terminated | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Terminated | |
| Fort Sam Houston, Texas, United States, 78234-3879 | |
| United States, Utah | |
| Active, not recruiting | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Active, not recruiting | |
| Fairfax, Virginia, United States, 22031 | |
| Active, not recruiting | |
| Richmond, Virginia, United States, 23249 | |
| Active, not recruiting | |
| Charlottesville, Virginia, United States, 22908 | |
| Australia | |
| Recruiting | |
| Nedlands, Australia, 6009 | |
| Recruiting | |
| Fremantle, Australia, 6160 | |
| Recruiting | |
| Sydney, Australia, 2139 | |
| Recruiting | |
| Darlinghurst, Australia, 2010 | |
| Recruiting | |
| Melbourne, Australia, 3186 | |
| Austria | |
| Recruiting | |
| Wien, Austria, 1090 | |
| Recruiting | |
| Graz, Austria, 8036 | |
| Recruiting | |
| Wien, Austria, 1160 | |
| Recruiting | |
| Linz, Austria, 4010 | |
| Recruiting | |
| Innsbruck, Austria, 6020 | |
| Recruiting | |
| Oberndorf, Austria, 5110 | |
| Belgium | |
| Active, not recruiting | |
| Bruxelles, Belgium, 1000 | |
| Active, not recruiting | |
| Antwerpen, Belgium, 2650 | |
| Active, not recruiting | |
| Gent, Belgium, 9000 | |
| Active, not recruiting | |
| Kortrijk, Belgium, 8500 | |
| Active, not recruiting | |
| Liege, Belgium, 4000 | |
| Active, not recruiting | |
| Bruxelles, Belgium, 1020 | |
| Active, not recruiting | |
| Bruxelles, Belgium, 1070 | |
| Brazil | |
| Active, not recruiting | |
| Porto Alegre, Brazil, 90035-003 | |
| Active, not recruiting | |
| Sao Paulo, Brazil, 04023-900 | |
| Active, not recruiting | |
| Brasilia, Brazil, 70335-000 | |
| Active, not recruiting | |
| Campinas, Brazil, 13012-970 | |
| Recruiting | |
| Sorocaba, Brazil | |
| Active, not recruiting | |
| Porto Alegre, Brazil, 90020-090 | |
| Active, not recruiting | |
| Vitoria, Brazil, 29043-260 | |
| Active, not recruiting | |
| Sao Luis, Brazil, 78048-790 | |
| Active, not recruiting | |
| Campinas, Brazil, 13081-970 | |
| Active, not recruiting | |
| Santo Andre, Brazil, 09060-650 | |
| Recruiting | |
| Ribeirão Preto, Brazil, 14049-900 | |
| Active, not recruiting | |
| Rio de Janeiro, Brazil, 20020 | |
| Canada, Alberta | |
| Recruiting | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Ontario | |
| Recruiting | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Germany | |
| Recruiting | |
| Frankfurt Am Main, Germany, 60590 | |
| Recruiting | |
| Tübingen, Germany, 72076 | |
| Recruiting | |
| Hamburg, Germany, 20099 | |
| Recruiting | |
| Ulm, Germany, 89081 | |
| Recruiting | |
| Heidelberg, Germany, 69120 | |
| Recruiting | |
| Köln, Germany, 50924 | |
| Recruiting | |
| Berlin, Germany, 13353 | |
| Recruiting | |
| Berlin, Germany, 10969 | |
| Recruiting | |
| Bonn, Germany, 531105 | |
| Recruiting | |
| München, Germany, 81675 | |
| Recruiting | |
| Mainz, Germany, 55101 | |
| Recruiting | |
| Düsseldorf, Germany, 40237 | |
| Recruiting | |
| Düsseldorf, Germany, 40225 | |
| Recruiting | |
| Freiburg, Germany, 79106 | |
| Recruiting | |
| Kiel, Germany, 24105 | |
| Recruiting | |
| Essen, Germany, 45147 | |
| Not yet recruiting | |
| Giessen, Germany, 35392 | |
| Not yet recruiting | |
| Offenburg, Germany, 77654 | |
| Not yet recruiting | |
| Jena, Germany, 07740 | |
| Mexico | |
| Recruiting | |
| Puebla, Mexico, 72560 | |
| Not yet recruiting | |
| Guadalajara, Mexico, 44670 | |
| Not yet recruiting | |
| Mexico City, Mexico, 02990 | |
| Recruiting | |
| Mexico City, Mexico, 11649 | |
| Recruiting | |
| Mexicali, Mexico, 21000 | |
| Not yet recruiting | |
| Mexico City, Mexico, 14050 | |
| Recruiting | |
| Guadalajara, Mexico, 44340 | |
| Not yet recruiting | |
| Tijuana, Mexico, 22450 | |
| Puerto Rico | |
| Active, not recruiting | |
| Santurce, Puerto Rico, 00909 | |
| Switzerland | |
| Recruiting | |
| Zürich, Switzerland, 8091 | |
| Active, not recruiting | |
| Lausanne, Switzerland, 1005 | |
| Active, not recruiting | |
| St Gallen, Switzerland, 9007 | |
| Recruiting | |
| Lugano, Switzerland, 6903 | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche ( Disclosures Group ) |
| Study ID Numbers: | MV21371, 2007-004993-15 |
| Study First Received: | February 18, 2008 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00623428 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Anti-Infective Agents Liver Diseases Flaviviridae Infections Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Hepatitis C Angiogenesis Modulating Agents |
Growth Inhibitors RNA Virus Infections Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2a Interferon Alfa-2a Hepatitis C, Chronic |
