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

August 1, 2013 updated by: Human Genome Sciences Inc.

Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1331

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Perth, Australia, 6000
        • Royal Perth Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital Clinical School of Medicine University of New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Victoria, Australia, 3065
        • St Vincent's Hospital
      • Footscray, Victoria, Australia, 3011
        • Western Hospital
      • Heidelburg, Victoria, Australia, 3081
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitätsklinik Graz
      • Innsbruck, Austria, 6020
        • Univ.-Klinik fuer Innere Medizin
      • Wien, Austria, 1090
        • Medical University of Vienna
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Heritage Medical Research Clinic
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T5H 4B9
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3P1
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • University of Manitoba Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Dalhousie University
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University of Western Ontario Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital - General Campus
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University
  • Czech Republic
      • Brno, Czech Republic, 62500
        • Klinika infekcních chorob
      • Hradec Kralove, Czech Republic, 50005
        • Klinika Infekcních nemocí
      • Melnik, Czech Republic, 27601
        • Nemocnice s poliklinikou Melník
      • Opava, Czech Republic, 74601
        • Slezská nemocnice
      • Praha 2, Czech Republic, 12808
        • Vseobecna Fakultni Nemocnice
      • Praha 4, Czech Republic, 14000
        • Nuselska Poliklinika
      • Usti nad Labem, Czech Republic, 40001
        • Ambulance pro interni a infekcni nemoci
  • France
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Creteil, France, 94010
        • Hopital Henri Mondor
      • Lyon Cedex 02, France, 69288
        • CHU de Lyon, Hôpital de l'Hôtel Dieu
      • Marseille Cedex 08, France, 13285
        • Hôpital Saint-Joseph
      • Orleans, France, 45100
        • Hôpital de la Source
      • Paris, France, 75012
        • Hôpital Saint-Antoine
      • Paris, France, 75013
        • Hôpital Pitié-Salpêtrière
      • Pessac cedex, France, 33600
        • Hôpital Haut-Lévêque
      • Toulouse Cedex, France, 31059
        • CHU Purpan Clinique Dieulafoy
      • Vandoeuvre, France, 54511
        • Hôpital de Brabois
  • Germany
      • Berlin, Germany, 13353
        • UH Charite Berlin / Virchow Klinikum
      • Duesseldorf, Germany, 40255
        • Universitätsklinik Düsseldorf
      • Düsseldorf, Germany, 40237
        • Center for HIV and Hepatogastroenterology
      • Essen, Germany, 45122
        • UH Essen
      • Frankfurt / Main, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe-Universitaet
      • Freiburg, Germany, 79106
        • Albert-Ludwigs-Universitaet Freiburg
      • Hannover, Germany, 30623
        • Medizinische Hochschule Hannover (MHH)
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg
      • Leipzig, Germany, 4103
        • Universitätsklinikum Leipzig
      • Mainz, Germany, 55101
        • Johannes Gutenberg-Universitaet Mainz
      • Marl, Germany, 45770
        • Paracelsus Klinik der Stadt Marl
  • India
      • Ludhiana, India, 141001
        • Dayanand Medical College and Hospital
      • Mumbai, India, 400 0026
        • Jaslok Hospital and Research Centre and Breach Candy Hospital,
      • New Delhi, India, 110 002
        • G.B.Pant Hospital
  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Bnei-Zion Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization
      • Nazareth, Israel, 16100
        • Holy Family Hospital
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center Beilinson Campus
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S.Orsola Malpighi
      • Milano, Italy, 20122
        • IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano
      • Napoli, Italy, 80131
        • Seconda Università di Napoli c/o Secondo Policlinico
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
      • Pavia, Italy, 27100
        • I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia
      • San Giovanni Rotondo (FG), Italy, 71013
        • Casa Sollievo Della Sofferenza IRCCS
      • Torino, Italy, 10126
        • Azienda Ospedaliera S. Giovanni Battista Molinette
  • Poland
      • Białystok, Poland, 15-540
        • Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego
      • Chorzow, Poland, 41-500
        • Szpital Specjalistyczny
      • Kielce, Poland, 25-317
        • Wojewodzki Szpital Zespolony
      • Kraków, Poland, 31-531
        • Szpital Uniwersytecki w Krakowie
      • Warszawa, Poland, 01-201
        • Akademia Medyczna
      • Warszawa, Poland, 01-201
        • Wojewódzki Szpital Zaka?ny
      • Wrocław, Poland, 51-149
        • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
      • Łódź, Poland, 91-347
        • Uniwersytet Medyczny
  • Puerto Rico
      • Santurce, Puerto Rico, 909
        • Fundacion De Investigacion de Diego
  • Romania
      • Bucharest, Romania, 20125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 22328
        • Institutul Clinic Fundeni
      • Bucharest, Romania, 30303
        • Spitalul Clinic Dr.Victor Babes
      • Cluj-Napoca, Romania, 400162
        • Spitalul Clinic de Adulti Cluj-Napoca
      • Lasi, Romania, 700111
        • Institutul de Gastroenterologie si Hepatologie
  • Spain
      • Badalona - Barcelona, Spain, 8916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 8036
        • Hospital Clinic i Provincial
      • Barcelona, Spain, 8035
        • Hopital Universitari Vall d'Hebron
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28029
        • Hospital Carlos III
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario De Valencia
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Medical Centre
      • London, United Kingdom, E1 2AT
        • Royal London Hospital
      • London, United Kingdom, W2 1PG
        • Imperial College London St Mary's Hospital Campus
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust Queens Medical Centre Campus
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
    • California
      • Fresno, California, United States, 93702
        • UCSF Fresno
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine
      • Los Angeles, California, United States, 90073
        • UCLA / West LA VAMC
      • Pasadena, California, United States, 91105
        • Huntington Medical Research Institutes
      • San Diego, California, United States, 92103-8707
        • University California-San Diego
      • San Diego, California, United States, 92123
        • San Diego Digestive Diseases Consultants, Inc
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Francisco, California, United States, 94143-0538
        • University of California at San Francisco
    • Colorado
      • Denver, Colorado, United States, 80262-0001
        • University Of Colorado
      • Englewood, Colorado, United States, 80113
        • University of Colorado Health Sciences Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida - Gainesville
      • Jacksonville, Florida, United States, 32209
        • Shands Jacksonville Medical Center
      • Jacksonville, Florida, United States, 32216
        • Mayo Clinic Transplant Center
      • Miami, Florida, United States, 33125
        • VA Health Care System
      • Miami, Florida, United States, 33136-1051
        • University of Miami
      • N. Miami Beach, Florida, United States, 33162
        • Venture Research Institute
      • Sarasota, Florida, United States, 34243
        • University Hepatitis Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, United States, 30309
        • GI of Atlanta
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Gastroenterology Associates
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Alan D Tice, MD, LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiania University School of Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21021-1544
        • University of Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Center for Viral Hepatits
      • Laurel, Maryland, United States, 20707
        • Maryland Digestive Disease Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialist
    • Missouri
      • St Louis, Missouri, United States, 63104
        • St. Louis University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • New York Hospital - Cornell
      • New York, New York, United States, 10029
        • Faculty Practice Associates
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27705
        • Duke Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 95267-0595
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of University of PA
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Memphis Gastroenterology Group
      • Nashville, Tennessee, United States, 37211
        • Nashville Gastrointestinal Specialists
      • Nashville, Tennessee, United States, 37205
        • Nashville Gastroenterology
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75208
        • Liver Institute at Methodist Dallas
      • Dallas, Texas, United States, 75390-8887
        • UT Southwesten Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Granbury, Texas, United States, 76048
        • GI & Liver Assoicates
      • Houston, Texas, United States, 77030-2312
        • Liver Specialist of Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Inova Fairfax Hospital
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Ctr
    • Washington
      • Seattle, Washington, United States, 98195-6174
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5124
        • University of Wisconsin-Madison
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
Drug: peginterferon alfa-2a
180 mcg once a week for 48 weeks
Drug: Ribavirin

1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects

=,> 75kg)
Experimental: 2
900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Drug: Ribavirin

1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects

=,> 75kg)

Drug: albumin interferon alfa-2b
900 mcg or 1200mcg every two week for 48 weeks
Experimental: 3
1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Drug: Ribavirin

1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects

=,> 75kg)

Drug: albumin interferon alfa-2b
900 mcg or 1200mcg every two week for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virologic response (SVR)
Time Frame: Week 72
Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Rapid virologic response
Time Frame: Week 4
Week 4
Early virologic response
Time Frame: Week 12
Week 12
Undetectable HCV RNA
Time Frame: Week 24 and Week 48
Week 24 and Week 48
Normalization of ALT (a liver enzyme)
Time Frame: Week 48
Week 48
Quality of life evaluation
Time Frame: throughout the entire study
throughout the entire study
Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing)
Time Frame: Throughout the entire study
Throughout the entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Genome Sciences Inc.

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 20, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

August 8, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGS1008-C1060
  • ACHIEVE-1 (Other Identifier: Human Genome Sciences Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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