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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00077636 |
Purpose
This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. 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, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection |
| Enrollment: | 1469 |
| Study Completion Date: | March 2006 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 16 weeks
Drug: Copegus
400mg po bid for 16 weeks
|
| 2: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 24 weeks
Drug: Copegus
400mg po bid for 24 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 | |
| MOBILE, Alabama, United States, 36693 | |
| United States, Alaska | |
| ANCHORAGE, Alaska, United States, 99508 | |
| United States, Arizona | |
| SCOTTSDALE, Arizona, United States, 85259 | |
| PHOENIX, Arizona, United States, 85006 | |
| United States, Arkansas | |
| LITTLE ROCK, Arkansas, United States, 72205 | |
| United States, California | |
| LONG BEACH, California, United States, 90822 | |
| LA JOLLA, California, United States, 92037-1030 | |
| PALO ALTO, California, United States, 94304-1509 | |
| SAN DIEGO, California, United States, 92154 | |
| SAN FRANCISCO, California, United States, 94121 | |
| SAN FRANCISCO, California, United States, 94115 | |
| LOS ANGELES, California, United States, 90048 | |
| SACRAMENTO, California, United States, 95825-2115 | |
| SAN DIEGO, California, United States, 92105 | |
| SAN DIEGO, California, United States, 92123 | |
| SAN LUIS OBISPO, California, United States, 93401 | |
| United States, Colorado | |
| LITTLETON, Colorado, United States, 80120 | |
| United States, Connecticut | |
| FARMINGTON, Connecticut, United States, 06030 | |
| United States, Florida | |
| SARASOTA, Florida, United States, 34243 | |
| MIAMI, Florida, United States, 33136 | |
| WELLINGTON, Florida, United States, 33414 | |
| GAINESVILLE, Florida, United States, 32610-0214 | |
| JACKSONVILLE, Florida, United States, 32209 | |
| JACKSONVILLE, Florida, United States, 32207 | |
| ORLANDO, Florida, United States, 32803 | |
| TAMPA, Florida, United States, 33612 | |
| PENSACOLA, Florida, United States, 32514 | |
| United States, Georgia | |
| AUSTELL, Georgia, United States, 30106 | |
| ATLANTA, Georgia, United States, 30309 | |
| United States, Hawaii | |
| HONOLULU, Hawaii, United States, 96817 | |
| United States, Idaho | |
| BOISE, Idaho, United States, 83702 | |
| United States, Illinois | |
| MOLINE, Illinois, United States, 61265 | |
| United States, Indiana | |
| INDIANAPOLIS, Indiana, United States, 46202 | |
| United States, Iowa | |
| IOWA CITY, Iowa, United States, 52242 | |
| IOWA CITY, Iowa, United States, 52246 | |
| United States, Louisiana | |
| NEW ORLEANS, Louisiana, United States, 70112 | |
| BATON ROUGE, Louisiana, United States, 70805 | |
| United States, Maryland | |
| BALTIMORE, Maryland, United States, 21205 | |
| BALTIMORE, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| BOSTON, Massachusetts, United States, 02118 | |
| BURLINGTON, Massachusetts, United States, 01805 | |
| BOSTON, Massachusetts, United States, 02720 | |
| WORCESTER, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| DETROIT, Michigan, United States, 48202-2689 | |
| ANN ARBOR, Michigan, United States, 48109-0362 | |
| United States, Minnesota | |
| PLYMOUTH, Minnesota, United States, 55446 | |
| MINNEAPOLIS, Minnesota, United States, 55417 | |
| United States, Missouri | |
| ST LOUIS, Missouri, United States, 63104 | |
| United States, New Mexico | |
| ALBUQUERQUE, New Mexico, United States, 87108 | |
| United States, New York | |
| BRONX, New York, United States, 10468 | |
| MANHASSET, New York, United States, 11030 | |
| WILLIAMSVILLE, New York, United States, 14221 | |
| NEW YORK, New York, United States, 10003 | |
| NEW YORK, New York, United States, 10021 | |
| BINGHAMTON, New York, United States, 13903 | |
| BAYSIDE, New York, United States, 11358 | |
| United States, North Carolina | |
| CHAPEL HILL, North Carolina, United States, 27599-7080 | |
| CHARLOTTE, North Carolina, United States, 28203 | |
| DURHAM, North Carolina, United States, 27710 | |
| FAYETTEVILLE, North Carolina, United States, 28304 | |
| United States, Ohio | |
| CINCINNATI, Ohio, United States, 45267-0595 | |
| CLEVELAND, Ohio, United States, 44106 | |
| United States, Oregon | |
| PORTLAND, Oregon, United States, 97220 | |
| United States, Pennsylvania | |
| PITTSBURGH, Pennsylvania, United States, 15213 | |
| LANCASTER, Pennsylvania, United States, 17604-3200 | |
| HERSHEY, Pennsylvania, United States, 17033 | |
| United States, Rhode Island | |
| PROVIDENCE, Rhode Island, United States, 02905 | |
| CRANSTON, Rhode Island, United States, 02920 | |
| United States, Tennessee | |
| GERMANTOWN, Tennessee, United States, 38138 | |
| United States, Texas | |
| DALLAS, Texas, United States, 75235-9151 | |
| FORT SAM HOUSTON, Texas, United States, 78234-3879 | |
| HOUSTON, Texas, United States, 77030 | |
| Dallas, Texas, United States, 75203 | |
| United States, Utah | |
| SALT LAKE CITY, Utah, United States, 84121 | |
| United States, Vermont | |
| WHITE RIVER JUNCTION, Vermont, United States, 05009-0001 | |
| United States, Virginia | |
| RICHMOND, Virginia, United States, 23249 | |
| CHESAPEAKE, Virginia, United States, 23320-1706 | |
| CHARLOTTESVILLE, Virginia, United States, 22902 | |
| FALLS CHURCH, Virginia, United States, 22042 | |
| United States, Washington | |
| SEATTLE, Washington, United States, 98195 | |
| KIRKLAND, Washington, United States, 98034 | |
| SEATTLE, Washington, United States, 98133 | |
| BELLEVUE, Washington, United States, 98004 | |
| SPOKANE, Washington, United States, 99220-3649 | |
| PUYALLUP, Washington, United States, 98372 | |
| United States, Wisconsin | |
| MADISON, Wisconsin, United States, 53792 | |
| United States, Wyoming | |
| CHEYENNE, Wyoming, United States, 82001 | |
| Australia | |
| WOOLLOONGABBA, Australia, 4102 | |
| BRISBANE, Australia, 4029 | |
| MELBOURNE, Australia, 3181 | |
| ADELAIDE, Australia, 5000 | |
| KINGSWOOD, Australia | |
| Canada, Alberta | |
| EDMONTON, Alberta, Canada, T6G 2B7 | |
| Canada, Ontario | |
| DOWNSVIEW, Ontario, Canada, M3N 2V7 | |
| MISSISSAUGA, Ontario, Canada, L5M 2V8 | |
| France | |
| VANDOEUVRE-LES-NANCY, France, 54511 | |
| TOULOUSE, France, 31059 | |
| CRETEIL, France, 94010 | |
| NICE, France, 06202 | |
| GRENOBLE, France, 38043 | |
| RENNES, France, 35033 | |
| CLICHY, France, 92118 | |
| STRASBOURG, France, 67091 | |
| MARSEILLE, France, 13001 | |
| Germany | |
| HOMBURG, Germany, 66424 | |
| KIEL, Germany, 24105 | |
| BERLIN, Germany, 13353 | |
| FREIBURG, Germany, 79106 | |
| DÜSSELDORF, Germany, 40225 | |
| HANNOVER, Germany, 30623 | |
| Italy | |
| PISA, Italy, 56124 | |
| MILANO, Italy, 20121 | |
| BOLOGNA, Italy, 40138 | |
| BERGAMO, Italy, 24128 | |
| NAPOLI, Italy, 80131 | |
| PAVIA, Italy, 27100 | |
| New Zealand | |
| OTAHUHU, New Zealand | |
| Puerto Rico | |
| SANTURCE, Puerto Rico, 00909 | |
| PONCE, Puerto Rico, 00716 | |
| SAN JUAN, Puerto Rico, 00936-5067 | |
| SAN JUAN, Puerto Rico, 00921-3200 | |
| Spain | |
| VALENCIA, Spain, 46014 | |
| SEVILLA, Spain, 41013 | |
| MADRID, Spain, 28006 | |
| BARCELONA, Spain, 08803 | |
| MADRID, Spain, 28007 | |
| BARAKALDO, Spain, 48903 | |
| MADRID, Spain, 28034 | |
| BARCELONA, Spain, 08025 | |
| MADRID, Spain, 08029 | |
| BADALONA, Spain, 08915 | |
| 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: | NV17317 |
| Study First Received: | February 10, 2004 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077636 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Interferon-alpha Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human Angiogenesis Inhibitors |
Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
|
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 |
