A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
NCT ID: NCT00394277
Last Updated: 2010-08-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1175 participants
INTERVENTIONAL
2007-02-28
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
NCT00077649
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection
NCT00353418
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
NCT00377182
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response
NCT00623428
A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
NCT01033448
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PEG-IFN 180 µg + Ribavirin 1200 mg
peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Ribavirin
1200 mg po daily for 48 weeks
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Ribavirin
1400-1600 mg po daily for 48 weeks
PEG-IFN 360/180 µg + Ribavirin 1200 mg
Ribavirin
1200 mg po daily for 48 weeks
peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
Ribavirin
1400-1600 mg po daily for 48 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Ribavirin
1200 mg po daily for 48 weeks
peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
Ribavirin
1400-1600 mg po daily for 48 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Other forms of liver disease, including liver cancer
* Human immunodeficiency virus infection
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hoffmann-La Roche
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Fresno, California, United States
La Jolla, California, United States
Lancaster, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
San Marcos, California, United States
Ventura, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Sarasota, Florida, United States
Atlanta, Georgia, United States
Austell, Georgia, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Winfield, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Iowa City, Iowa, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Ypsilanti, Michigan, United States
Plymouth, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Egg Harbour Township, New Jersey, United States
Vineland, New Jersey, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Williamsville, New York, United States
Yonkers, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Fayetteville, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Cranston, Rhode Island, United States
Providence, Rhode Island, United States
Columbia, South Carolina, United States
Germantown, Tennessee, United States
West Nashville, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Sam Houston, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Annandale, Virginia, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Vancouver, Washington, United States
Casper, Wyoming, United States
Cheyenne, Wyoming, United States
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Caixa, , Brazil
Campinas, , Brazil
Juiz de Fora, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Salvador, , Brazil
São José do Rio Preto, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Kolding, , Denmark
Odense, , Denmark
Clermont-Ferrand, , France
Clichy, , France
Lille, , France
Lyon, , France
Rouen, , France
Strasbourg, , France
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Giessen, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Kiel, , Germany
Tübingen, , Germany
Békéscsaba, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Gyula, , Hungary
Pécs, , Hungary
Szombathely, , Hungary
Amsterdam, , Netherlands
Leiden, , Netherlands
Rotterdam, , Netherlands
Bydgoszcz, , Poland
Chorzów, , Poland
Kielce, , Poland
Lodz, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Santurce, , Puerto Rico
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Constanța, , Romania
Iași, , Romania
Timișoara, , Romania
Jaloslave, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Stavropol, , Russia
Stockholm, , Sweden
Uppsala, , Sweden
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Plymouth, , United Kingdom
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NV18210
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.