Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients | NCT00402428 | Trialant

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients | NCT00402428 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Key Inclusion Criteria:

Diagnosis of chronic hepatitis C.

Liver biopsy performed within 2 years of Day 0 or during screening.

Infected with hepatitis C virus genotype 1.

Interferon alfa treatment naïve (ie, have never been treated with an interferon product).

Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.

Have compensated liver disease.

Key Exclusion Criteria:

Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.

History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.

Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).

Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.

A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).

Active seizure disorder within the last 2 years.

Organ transplant other than cornea and hair transplant.

Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).

Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).

Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.

Received any experimental agent within 28 days prior to Day 0.

University of Alabama at Birmingham

Birmingham, Alabama 35294, United States

Mayo Clinic Hospital

Phoenix, Arizona 85054, United States

UCSF Fresno

Fresno, California 93702, United States

Scripps Clinic

La Jolla, California 92037, United States

USC Keck School of Medicine

Los Angeles, California 90033, United States

Cedars-Sinai Medical Center

Los Angeles, California 90048, United States

UCLA / West LA VAMC

Los Angeles, California 90073, United States

Huntington Medical Research Institutes

Pasadena, California 91105, United States

University California-San Diego

San Diego, California 92103-8707, United States

San Diego Digestive Diseases Consultants, Inc

San Diego, California 92123, United States

VA San Diego Healthcare

San Diego, California 92161, United States

California Pacific Medical Center

San Francisco, California 94115, United States

University of California at San Francisco

San Francisco, California 94143-0538, United States

University of Colorado

Denver, Colorado 80262-0001, United States

University of Colorado Health Sciences Ctr

Englewood, Colorado 80113, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia 20307, United States

University of Florida - Gainesville

Gainesville, Florida 32610, United States

Shands Jacksonville Medical Center

Jacksonville, Florida 32209, United States

Mayo Clinic Transplant Center

Jacksonville, Florida 32216, United States

Va Health Care System

Miami, Florida 33125, United States

University of Miami

Miami, Florida 33136-1051, United States

Venture Research Institute

North Miami Beach, Florida 33162, United States

University Hepatitis Center

Sarasota, Florida 34243, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia 30308, United States

GI of Atlanta

Atlanta, Georgia 30309, United States

Northwest Georgia Gastroenterology Associates

Marietta, Georgia 30060, United States

Alan D Tice, MD, LLC

Honolulu, Hawaii 96813, United States

Northwestern Memorial Hospital

Chicago, Illinois 60611, United States

Indiania University School of Medicine

Indianapolis, Indiana 46202, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242, United States

University of Louisville

Louisville, Kentucky 40202, United States

Tulane University Health Sciences Center

New Orleans, Louisiana 70112, United States

University of Maryland

Baltimore, Maryland 21021-1544, United States

Johns Hopkins Center for Viral Hepatits

Baltimore, Maryland 21287, United States

Maryland Digestive Disease Center

Laurel, Maryland 20707, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215, United States

Henry Ford Health System

Detroit, Michigan 48202, United States

Mayo Clinic

Rochester, Minnesota 55905, United States

Digestive Health Specialist

Tupelo, Mississippi 38801, United States

St. Louis University

St Louis, Missouri 63104, United States

University of New Mexico

Albuquerque, New Mexico 87131-0001, United States

North Shore University Hospital

Manhasset, New York 11030, United States

New York Hospital - Cornell

New York, New York 10021, United States

Faculty Practice Associates

New York, New York 10029, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599-7584, United States

Duke Medical Center

Durham, North Carolina 27705, United States

University of Cincinnati

Cincinnati, Ohio 95267-0595, United States

Hospital of University of PA

Philadelphia, Pennsylvania 19104, United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107, United States

Memphis Gastroenterology Group

Germantown, Tennessee 38138, United States

Nashville Gastroenterology

Nashville, Tennessee 37205, United States

Nashville Gastrointestinal Specialists

Nashville, Tennessee 37211, United States

Liver Institute at Methodist Dallas

Dallas, Texas 75208, United States

Baylor University Medical Center

Dallas, Texas 75246, United States

UT Southwesten Medical Center

Dallas, Texas 75390-8887, United States

Brooke Army Medical Center

Fort Sam Houston, Texas 78234, United States

GI & Liver Assoicates

Granbury, Texas 76048, United States

Liver Specialist of Texas

Houston, Texas 77030-2312, United States

Alamo Medical Research

San Antonio, Texas 78215, United States

INOVA Fairfax Hospital

Annandale, Virginia 22003, United States

Metropolitan Research

Fairfax, Virginia 22031, United States

Virginia Commonwealth University Medical Ctr

Richmond, Virginia 23298, United States

University of Washington

Seattle, Washington 98195-6174, United States

University of Wisconsin-Madison

Madison, Wisconsin 53792-5124, United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050, Australia

Concord Repatriation General Hospital

Concord, New South Wales 2139, Australia

St George Hospital Clinical School of Medicine University of New South Wales

Kogarah, New South Wales 2217, Australia

John Hunter Hospital

New Lambton, New South Wales 2305, Australia

Westmead Hospital

Westmead, New South Wales 2145, Australia

Greenslopes Private Hospital

Greenslopes, Queensland 4120, Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000, Australia

Monash Medical Centre

Clayton, Victoria 3168, Australia

St Vincent's Hospital

Fitzroy, Victoria, Victoria 3065, Australia

Western Hospital

Footscray, Victoria 3011, Australia

Austin Hospital

Heidelburg, Victoria 3081, Australia

The Alfred Hospital

Melbourne, Victoria 3004, Australia

Royal Melbourne Hospital

Parkville, Victoria 3050, Australia

Fremantle Hospital

Fremantle, Western Australia 6160, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia 6009, Australia

Royal Perth Hospital

Perth, 6000, Australia

Medizinische Universitätsklinik Graz

Graz, 8036, Austria

Univ.-Klinik fuer Innere Medizin

Innsbruck, 6020, Austria

Medical University of Vienna

Vienna, 1090, Austria

Heritage Medical Research Clinic

Calgary, Alberta T2N 4N1, Canada

University of Alberta

Edmonton, Alberta T5H 4B9, Canada

University of Alberta Hospital

Edmonton, Alberta T6G 2X8, Canada

Vancouver General Hospital

Vancouver, British Columbia V5Z 3P1, Canada

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba R3E 3P4, Canada

Dalhousie University

Halifax, Nova Scotia B3H 2Y9, Canada

University of Western Ontario Hospital

London, Ontario N6A 5A5, Canada

Ottawa Hospital - General Campus

Ottawa, Ontario K1H 8L6, Canada

Toronto General Hospital

Toronto, Ontario M5G 2N2, Canada

Toronto Western Hospital

Toronto, Ontario M5T 2S8, Canada

McGill University

Montreal, Quebec H3A 1A1, Canada

Klinika infekcních chorob

Brno, 62500, Czechia

Klinika Infekcních nemocí

Hradec Králové, 50005, Czechia

Nemocnice s poliklinikou Melník

Mělník, 27601, Czechia

Slezská nemocnice

Opava, 74601, Czechia

Vseobecna fakultní nemocnice

Prague, 12808, Czechia

Nuselská poliklinika

Prague, 14000, Czechia

Ambulance pro interni a infekcni nemoci

Ústí nad Labem, 40001, Czechia

Hopital Beaujon

Clichy, 92110, France

Hopital Henri Mondor

Créteil, 94010, France

CHU de Lyon, Hôpital de l'Hôtel Dieu

Lyon, 69288, France

Hopital Saint-Joseph

Marseille, 13285, France

Hopital de La Source

Orléans, 45100, France

Hôpital Saint-Antoine

Paris, 75012, France

Hopital Pitie-Salpetriere

Paris, 75013, France

Hopital Haut-Leveque

Pessac, 33600, France

CHU Purpan Clinique Dieulafoy

Toulouse, 31059, France

Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

UH Charite Berlin / Virchow Klinikum

Berlin, 13353, Germany

Center for HIV and Hepatogastroenterology

Düsseldorf, 40237, Germany

Universitätsklinik Düsseldorf

Düsseldorf, 40255, Germany

UH Essen

Essen, 45122, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, 60590, Germany

Albert-Ludwigs-Universitaet Freiburg

Freiburg im Breisgau, 79106, Germany

Medizinische Hochschule Hannover (MHH)

Hanover, 30623, Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Universitätsklinikum Leipzig

Leipzig, 4103, Germany

Johannes Gutenberg-Universitaet Mainz

Mainz, 55101, Germany

Paracelsus Klinik der Stadt Marl

Marl, 45770, Germany

Dayanand Medical College and Hospital

Ludhiana, 141001, India

Jaslok Hospital and Research Centre and Breach Candy Hospital,

Mumbai, 400 0026, India

G.B.Pant Hospital

New Delhi, 110 002, India

Bnei-Zion Medical Center

Haifa, 31048, Israel

Rambam Health Care Campus

Haifa, 31096, Israel

Hadassah Medical Organization

Jerusalem, 91120, Israel

Holy Family Hospital

Nazareth, 16100, Israel

Rabin Medical Center Beilinson Campus

Petah Tikva, 49100, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Policlinico S.Orsola Malpighi

Bologna, 40138, Italy

IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano

Milan, 20122, Italy

Seconda Università di Napoli c/o Secondo Policlinico

Naples, 80131, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia

Pavia, 27100, Italy

Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo (FG), 71013, Italy

Azienda Ospedaliera S. Giovanni Battista Molinette

Torino, 10126, Italy

Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego

Bialystok, 15-540, Poland

Szpital Specjalistyczny

Chorzów, 41-500, Poland

Wojewódzki Szpital Zespolony

Kielce, 25-317, Poland

Szpital Uniwersytecki w Krakowie

Krakow, 31-531, Poland

Uniwersytet Medyczny

Lodz, 91-347, Poland

Akademia Medyczna

Warsaw, 01-201, Poland

Wojewódzki Szpital Zaka?ny

Warsaw, 01-201, Poland

Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

Wroclaw, 51-149, Poland

Fundacion de Investigacion de Diego

Santurce, 909, Puerto Rico

Spitalul Clinic Colentina

Bucharest, 20125, Romania

Institutul Clinic Fundeni

Bucharest, 22328, Romania

Spitalul Clinic Dr.Victor Babes

Bucharest, 30303, Romania

Spitalul Clinic de Adulti Cluj-Napoca

Cluj-Napoca, 400162, Romania

Institutul de Gastroenterologie si Hepatologie

Lasi, 700111, Romania

Hospital Universitari Germans Trias i Pujol

Badalona - Barcelona, 8916, Spain

Hopital Universitari Vall d'Hebron

Barcelona, 8035, Spain

Hospital Clinic i Provincial

Barcelona, 8036, Spain

Hospital Universitario La Princesa

Madrid, 28006, Spain

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Hospital Carlos III

Madrid, 28029, Spain

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

Queen Elizabeth Medical Centre

Birmingham, B15 2TH, United Kingdom

Royal London Hospital

London, E1 2AT, United Kingdom

Imperial College London St Mary's Hospital Campus

London, W2 1PG, United Kingdom

Nottingham University Hospitals NHS Trust Queens Medical Centre Campus

Nottingham, NG7 2UH, United Kingdom

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom