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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00394277 |
Purpose
This 4 arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus,and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C genotype 1 infection of high viral titer, and baseline body weight >=85kg, will be randomized to one of 4 groups, to receive a)PEGASYS 180 micrograms sc weekly plus Copegus 1200mg po daily, b)PEGASYS 180 micrograms sc weekly plus Copegus 1400-1600mg po daily, c)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1200mg po daily or d)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1400-1600mg po daily. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: Copegus |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-blind Study of the Effect on Sustained Viral Response, and the Safety, of Standard or 360 ug PEGASYS Induction Dosing in Combination With Standard or Higher Dose Copegus in Treatment-naive Chronic Hepatitis C Patients Weighing >85kg With Genotype 1 High Viral Titer Infection |
| Estimated Enrollment: | 1175 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | March 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1200mg po daily for 48 weeks
|
| 2: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1400-1600mg po daily for 48 weeks
|
| 3: Experimental |
Drug: Copegus
1200mg po daily for 48 weeks
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
360 micrograms sc weekly decreasing to 180 micrograms sc weekly for 48 weeks
|
| 4: Experimental |
Drug: Copegus
1400-1600mg po daily for 48 weeks
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
360 micrograms sc weekly decreasing to 180 micrograms sc weekly for 48 weeks
|
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
Hide Study Locations| United States, Alabama | |
| BIRMINGHAM, Alabama, United States, 35294 | |
| HUNTSVILLE, Alabama, United States, 35801 | |
| United States, Alaska | |
| ANCHORAGE, Alaska, United States, 99508 | |
| United States, Arizona | |
| PHOENIX, Arizona, United States, 85006 | |
| United States, California | |
| SAN DIEGO, California, United States, 92105 | |
| LOS ANGELES, California, United States, 90095 | |
| SAN DIEGO, California, United States, 92123 | |
| LANCASTER, California, United States, 93534 | |
| SACRAMENTO, California, United States, 95817 | |
| SAN LUIS OBISPO, California, United States, 93401 | |
| SAN DIEGO, California, United States, 92154 | |
| LOS ANGELES, California, United States, 90045 | |
| FRESNO, California, United States, 93721 | |
| VENTURA, California, United States, 93003 | |
| SAN MARCOS, California, United States, 92069 | |
| LA JOLLA, California, United States, 92037-1030 | |
| SAN DIEGO, California, United States, 92103-8465 | |
| United States, Colorado | |
| AURORA, Colorado, United States, 80045 | |
| ENGLEWOOD, Colorado, United States, 80113 | |
| United States, District of Columbia | |
| WASHINGTON, District of Columbia, United States, 20010 | |
| WASHINGTON, District of Columbia, United States, 20037 | |
| United States, Florida | |
| SARASOTA, Florida, United States, 34243 | |
| JACKSONVILLE, Florida, United States, 32209 | |
| NORTH MIAMI BEACH, Florida, United States, 33162 | |
| JACKSONVILLE, Florida, United States, 32256 | |
| MIAMI, Florida, United States, 33136-1051 | |
| United States, Georgia | |
| ATLANTA, Georgia, United States, 30308 | |
| MARIETTA, Georgia, United States, 30060 | |
| AUSTELL, Georgia, United States, 30106 | |
| United States, Hawaii | |
| HONOLULU, Hawaii, United States, 96817 | |
| United States, Illinois | |
| WINFIELD, Illinois, United States, 60190 | |
| CHICAGO, Illinois, United States, 60637 | |
| CHICAGO, Illinois, United States, 60612 | |
| United States, Indiana | |
| INDIANAPOLIS, Indiana, United States, 46202 | |
| United States, Iowa | |
| IOWA CITY, Iowa, United States, 52242-1081 | |
| DES MOINES, Iowa, United States, 50312 | |
| IOWA CITY, Iowa, United States, 52246 | |
| United States, Kentucky | |
| LOUISVILLE, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| NEW ORLEANS, Louisiana, United States, 70112 | |
| BATON ROUGE, Louisiana, United States, 70805 | |
| United States, Massachusetts | |
| WORCESTER, Massachusetts, United States, 01068 | |
| BOSTON, Massachusetts, United States, 02720 | |
| United States, Michigan | |
| YPSILANTI, Michigan, United States, 48197 | |
| DETROIT, Michigan, United States, 48210 | |
| United States, Minnesota | |
| PLYMOUTH, Minnesota, United States, 55446 | |
| United States, Missouri | |
| ST LOUIS, Missouri, United States, 63110 | |
| KANSAS CITY, Missouri, United States, 64131 | |
| ST LOUIS, Missouri, United States, 63104 | |
| United States, New Hampshire | |
| LEBANON, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| EGG HARBOUR TOWNSHIP, New Jersey, United States, 08234 | |
| VINELAND, New Jersey, United States, 08360 | |
| United States, New York | |
| BRONX, New York, United States, 10467 | |
| ROCHESTER, New York, United States, 14618 | |
| WILLIAMSVILLE, New York, United States, 14221 | |
| NEW YORK, New York, United States, 10029 | |
| YONKERS, New York, United States, 10701 | |
| NEW YORK, New York, United States, 10021 | |
| MANHASSET, New York, United States, 11030 | |
| United States, North Carolina | |
| ASHEVILLE, North Carolina, United States, 28801 | |
| CHAPEL HILL, North Carolina, United States, 27599-7080 | |
| FAYETTEVILLE, North Carolina, United States, 28304 | |
| United States, Ohio | |
| CLEVELAND, Ohio, United States, 44106 | |
| CLEVELAND, Ohio, United States, 44109 | |
| CINCINNATI, Ohio, United States, 45267 | |
| United States, Oklahoma | |
| TULSA, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| MEDFORD, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| LANCASTER, Pennsylvania, United States, 17604-3200 | |
| PHILADELPHIA, Pennsylvania, United States, 19107 | |
| PHILADELPHIA, Pennsylvania, United States, 19104 | |
| PITTSBURGH, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| CRANSTON, Rhode Island, United States, 02920 | |
| PROVIDENCE, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| COLUMBIA, South Carolina, United States, 29203 | |
| United States, Tennessee | |
| WEST NASHVILLE, Tennessee, United States, 37205 | |
| GERMANTOWN, Tennessee, United States, 38138 | |
| United States, Texas | |
| HOUSTON, Texas, United States, 77030 | |
| FORT SAM HOUSTON, Texas, United States, 78234-3879 | |
| DALLAS, Texas, United States, 75390 | |
| HOUSTON, Texas, United States, 77030 | |
| DALLAS, Texas, United States, 75246 | |
| DALLAS, Texas, United States, 75203 | |
| United States, Utah | |
| SALT LAKE CITY, Utah, United States, 84121 | |
| United States, Virginia | |
| CHESAPEAKE, Virginia, United States, 23320-1706 | |
| CHARLOTTESVILLE, Virginia, United States, 22906-0013 | |
| RICHMOND, Virginia, United States, 23249 | |
| ANNANDALE, Virginia, United States, 22003 | |
| FAIRFAX, Virginia, United States, 22031 | |
| United States, Washington | |
| TACOMA, Washington, United States, 98405 | |
| VANCOUVER, Washington, United States, 98664 | |
| SEATTLE, Washington, United States, 98104 | |
| United States, Wyoming | |
| CASPER, Wyoming, United States, 82609 | |
| CHEYENNE, Wyoming, United States, 82001 | |
| Belgium | |
| BRUXELLES, Belgium, 1200 | |
| GENT, Belgium, 9000 | |
| BRUXELLES, Belgium, 1030 | |
| LEUVEN, Belgium, 3000 | |
| BRUXELLES, Belgium, 1070 | |
| BRUXELLES, Belgium, 1000 | |
| Brazil | |
| PORTO ALEGRE, Brazil, 91350-200 | |
| SAO PAULO, Brazil, 01307 | |
| CAMPINAS, Brazil, 13083-888 | |
| SALVADOR, Brazil, 40110-170 | |
| PORTO ALEGRE, Brazil, 90035-003 | |
| CAIXA, Brazil, 18618-970 | |
| JUIZ DE FORA, Brazil, 36036-330 | |
| SAO JOSE DO RIO PRETO, Brazil, 15090-000 | |
| Canada, Alberta | |
| EDMONTON, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| VANCOUVER, British Columbia, Canada, V6Z 2K5 | |
| Canada, Manitoba | |
| WINNIPEG, Manitoba, Canada, R3E 3P4 | |
| Canada, Nova Scotia | |
| HALIFAX, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| OTTAWA, Ontario, Canada, K1H 8L6 | |
| TORONTO, Ontario, Canada, M5G 1L7 | |
| LONDON, Ontario, Canada, N6A 5A5 | |
| TORONTO, Ontario, Canada, M6H 3M1 | |
| TORONTO, Ontario, Canada, M5G 1X5 | |
| Canada, Quebec | |
| MONTREAL, Quebec, Canada, H1T 2M4 | |
| Denmark | |
| ODENSE, Denmark, 5000 | |
| KOLDING, Denmark, 6000 | |
| France | |
| LYON, France, 69288 | |
| LILLE, France, 59037 | |
| CLERMONT-FERRAND, France, 63000 | |
| CLICHY, France, 92118 | |
| ROUEN, France, 76031 | |
| STRASBOURG, France, 67091 | |
| Germany | |
| BERLIN, Germany, 13353 | |
| HAMBURG, Germany, 20246 | |
| KIEL, Germany, 24105 | |
| FRANKFURT AM MAIN, Germany, 60590 | |
| FREIBURG, Germany, 79106 | |
| KÖLN, Germany, 50937 | |
| HANNOVER, Germany, 30625 | |
| BONN, Germany, 531105 | |
| DÜSSELDORF, Germany, 40225 | |
| GIESSEN, Germany, 35392 | |
| TÜBINGEN, Germany, 72076 | |
| HEIDELBERG, Germany, 69120 | |
| Hungary | |
| PECS, Hungary, 7654 | |
| GYULA, Hungary, 5700 | |
| DEBRECEN, Hungary, 4032 | |
| BUDAPEST, Hungary, 1097 | |
| SZOMBATHELY, Hungary, 9700 | |
| BUDAPEST, Hungary, 1083 | |
| BEKESCSABA, Hungary, 5600 | |
| GYOR, Hungary, 9024 | |
| Netherlands | |
| ROTTERDAM, Netherlands, 3015 GD | |
| LEIDEN, Netherlands, 2333 ZA | |
| AMSTERDAM, Netherlands, 1091 AC | |
| Poland | |
| WROCLAW, Poland, 51-124 | |
| LODZ, Poland, 91-347 | |
| BYDGOSZCZ, Poland, 85-030 | |
| KIELCE, Poland, 25-317 | |
| CHORZOW, Poland, 41-500 | |
| WARSZAWA, Poland, 01-201 | |
| Puerto Rico | |
| SANTURCE, Puerto Rico, 00909 | |
| SAN JUAN, Puerto Rico, 00936-5067 | |
| PONCE, Puerto Rico, 00716 | |
| Romania | |
| BUCHAREST, Romania, 022328 | |
| BUCHAREST, Romania, 030303 | |
| BUCHAREST, Romania, 010825 | |
| CONSTANTA, Romania | |
| BUCHAREST, Romania, 021105 | |
| CLUJ-NAPOCA, Romania | |
| TIMISOARA, Romania | |
| IASI, Romania, 700111 | |
| Russian Federation | |
| MOSCOW, Russian Federation, 105229 | |
| MOSCOW, Russian Federation, 143420 | |
| SMOLENSK, Russian Federation, 214006 | |
| ST PETERSBURG, Russian Federation, 194044 | |
| NIZHNY NOVGOROD, Russian Federation, 603022 | |
| MOSCOW, Russian Federation, 119881 | |
| STAVROPOL, Russian Federation, 355017 | |
| MOSCOW, Russian Federation, 11/5 | |
| MOSCOW, Russian Federation, 115446 | |
| JALOSLAVE, Russian Federation, -- | |
| MOSCOW, Russian Federation, 127009 | |
| MOSCOW, Russian Federation, 117333 | |
| SAMARA, Russian Federation, 443011 | |
| Sweden | |
| STOCKHOLM, Sweden | |
| UPPSALA, Sweden, 75185 | |
| United Kingdom | |
| PLYMOUTH, United Kingdom, PL6 8DH | |
| LONDON, United Kingdom, SW17 0QT | |
| SOUTHAMPTON, United Kingdom, SO16 6YD | |
| NEWCASTLE UPON TYNE, United Kingdom, NE7 7DN | |
| LONDON, United Kingdom, SE5 9RS | |
| LONDON, United Kingdom, SW10 9TH | |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | NV18210 |
| Study First Received: | October 30, 2006 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00394277 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 |
