A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg
1 other identifier
interventional
1,175
15 countries
184
Brief Summary
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 (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2007
Typical duration for phase_4
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
July 5, 2010
CompletedAugust 3, 2010
July 1, 2010
2.2 years
October 30, 2006
May 27, 2010
July 30, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 68 (ie, on or after study day 477).
Week 72
Secondary Outcomes (3)
SVR-24 (Actual Treatment Period)
24 weeks after end of treatment
SVR-12 (Scheduled Treatment Period)
12 weeks after end of treatment
SVR-12 (Actual Treatment Period)
12 weeks after end of treatment
Study Arms (4)
PEG-IFN 180 µg + Ribavirin 1200 mg
EXPERIMENTALPEG-IFN 180 µg + Ribavirin 1400/1600 mg
EXPERIMENTALPEG-IFN 360/180 µg + Ribavirin 1200 mg
EXPERIMENTALPEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
EXPERIMENTALInterventions
180 µg sc weekly for 48 weeks
1200 mg po daily for 48 weeks
Eligibility Criteria
You may qualify if:
- Adult patients, ≥18 years of age
- CHC infection, genotype 1
- Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
- Baseline body weight ≥85 kg
- Liver biopsy (within 24 months of first dose) with results consistent with CHC
You may not qualify if:
- Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
- Other forms of liver disease, including liver cancer
- Human immunodeficiency virus infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (184)
Unknown Facility
Birmingham, Alabama, 35294, United States
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Huntsville, Alabama, 35801, United States
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Anchorage, Alaska, 99508, United States
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Phoenix, Arizona, 85006, United States
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Fresno, California, 93721, United States
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La Jolla, California, 92037-1030, United States
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Lancaster, California, 93534, United States
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Los Angeles, California, 90045, United States
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Los Angeles, California, 90095, United States
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Sacramento, California, 95817, United States
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San Diego, California, 92103-8465, United States
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San Diego, California, 92105, United States
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San Diego, California, 92123, United States
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San Diego, California, 92154, United States
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San Luis Obispo, California, 93401, United States
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San Marcos, California, 92069, United States
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Ventura, California, 93003, United States
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Aurora, Colorado, 80045, United States
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Englewood, Colorado, 80113, United States
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Washington D.C., District of Columbia, 20010, United States
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Washington D.C., District of Columbia, 20037, United States
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Jacksonville, Florida, 32209, United States
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Jacksonville, Florida, 32256, United States
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Miami, Florida, 33136-1051, United States
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North Miami Beach, Florida, 33162, United States
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Sarasota, Florida, 34243, United States
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Atlanta, Georgia, 30308, United States
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Austell, Georgia, 30106, United States
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Marietta, Georgia, 30060, United States
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Honolulu, Hawaii, 96817, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Winfield, Illinois, 60190, United States
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Indianapolis, Indiana, 46202, United States
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Des Moines, Iowa, 50312, United States
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Iowa City, Iowa, 52242-1081, United States
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Iowa City, Iowa, 52246, United States
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Louisville, Kentucky, 40202, United States
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Baton Rouge, Louisiana, 70805, United States
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New Orleans, Louisiana, 70112, United States
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Boston, Massachusetts, 02720, United States
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Worcester, Massachusetts, 01068, United States
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Detroit, Michigan, 48210, United States
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Ypsilanti, Michigan, 48197, United States
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Plymouth, Minnesota, 55446, United States
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Kansas City, Missouri, 64131, United States
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St Louis, Missouri, 63104, United States
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St Louis, Missouri, 63110, United States
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Lebanon, New Hampshire, 03756, United States
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Egg Harbour Township, New Jersey, 08234, United States
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Vineland, New Jersey, 08360, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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Rochester, New York, 14618, United States
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The Bronx, New York, 10467, United States
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Williamsville, New York, 14221, United States
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Yonkers, New York, 10701, United States
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Asheville, North Carolina, 28801, United States
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Chapel Hill, North Carolina, 27599-7080, United States
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Fayetteville, North Carolina, 28304, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44109, United States
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Tulsa, Oklahoma, 74104, United States
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Medford, Oregon, 97504, United States
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Lancaster, Pennsylvania, 17604-3200, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Cranston, Rhode Island, 02920, United States
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Providence, Rhode Island, 02903, United States
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Columbia, South Carolina, 29204, United States
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Germantown, Tennessee, 38138, United States
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West Nashville, Tennessee, 37205, United States
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Dallas, Texas, 75203, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390-9034, United States
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Fort Sam Houston, Texas, 78234-3879, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84121, United States
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Annandale, Virginia, 22003, United States
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Charlottesville, Virginia, 22906-0013, United States
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Chesapeake, Virginia, 23320-1706, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23249, United States
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Seattle, Washington, 98104, United States
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Tacoma, Washington, 98405, United States
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Vancouver, Washington, 98664, United States
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Casper, Wyoming, 82609, United States
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Cheyenne, Wyoming, 82001, United States
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Brussels, 1000, Belgium
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Brussels, 1030, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Caixa, 18618-970, Brazil
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Campinas, 13083-888, Brazil
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Juiz de Fora, 36036-330, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40110-170, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01307, Brazil
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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London, Ontario, N6A 5A5, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 1L7, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M6H 3M1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Kolding, 6000, Denmark
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Odense, 5000, Denmark
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Clermont-Ferrand, 63000, France
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Clichy, 92118, France
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Lille, 59037, France
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Lyon, 69288, France
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Rouen, 76031, France
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Strasbourg, 67091, France
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Berlin, 13353, Germany
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Bonn, 531105, Germany
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Cologne, 50924, Germany
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Düsseldorf, 40225, Germany
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Frankfurt am Main, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Giessen, 35392, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Kiel, 24105, Germany
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Tübingen, 72076, Germany
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Békéscsaba, 5600, Hungary
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Budapest, 1083, Hungary
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Budapest, 1097, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Pécs, 7654, Hungary
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Szombathely, 9700, Hungary
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Amsterdam, 1091 AC, Netherlands
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Leiden, 2333 ZA, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Bydgoszcz, 85-030, Poland
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Chorzów, 41-500, Poland
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Kielce, 25-317, Poland
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Lodz, 91-347, Poland
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Warsaw, 01-201, Poland
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Wroclaw, 51-124, Poland
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Ponce, 00716, Puerto Rico
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San Juan, 00936-5067, Puerto Rico
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Santurce, 00909, Puerto Rico
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Bucharest, 010825, Romania
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Bucharest, 021105, Romania
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Bucharest, 022328, Romania
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Bucharest, 030303, Romania
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Cluj-Napoca, Romania
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Constanța, Romania
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Iași, 700111, Romania
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Timișoara, Romania
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Jaloslave, Russia
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Moscow, 105229, Russia
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Moscow, 11/5, Russia
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Moscow, 115446, Russia
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Moscow, 117333, Russia
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Moscow, 119881, Russia
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Moscow, 127009, Russia
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Moscow, 143420, Russia
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Nizhny Novgorod, 603022, Russia
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Saint Petersburg, 194044, Russia
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Samara, 443011, Russia
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Smolensk, 214006, Russia
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Stavropol, 355017, Russia
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Stockholm, Sweden
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Uppsala, 75185, Sweden
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London, SE5 9RS, United Kingdom
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London, SW10 9TH, United Kingdom
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London, SW17 0QT, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. doi: 10.1053/j.gastro.2010.08.051. Epub 2010 Sep 30.
PMID: 20816836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 30, 2006
First Posted
October 31, 2006
Study Start
February 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
August 3, 2010
Results First Posted
July 5, 2010
Record last verified: 2010-07