Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

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

Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.

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 2/3 who are IFNa treatment naive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

933

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

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1093AAS
        • Unidad de Hepatología
      • Capital Federal, Buenos Aires, Argentina, C1121ABE
        • Fundacion CIDEA
      • Capital Federal, Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano
      • Pilar, Buenos Aires, Argentina, B1629AHJ
        • Hospital Universitario Austral
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Htal Pcial del Centenario
  • Australia
    • 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
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Gallipoli Research Foundation and Greenslopes Private Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Bribane & Women's 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
  • Belgium
      • Brussels, Belgium, 1200
        • UCL
      • Brussels, Belgium, 1020
        • CHU Brugmann ULB - site Victor Horta
      • Edegem, Belgium, 2650
        • University Hospital Antwerp
      • Gent, Belgium, 9000
        • Ghent University Hospital
      • Liège, Belgium, 4000
        • Chu Sart Tilman
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40110-170
        • Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
    • SP
      • Ribeirão Preto, SP, Brazil, 14049-900
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • São Paulo, SP, Brazil, 04023-900
        • Universidade Federal de São Paulo - UNIFESP
      • São Paulo, SP, Brazil, 04230-000
        • Hospital Heliopolis
      • São Paulo, SP, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da USP
  • 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
    • 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
  • France
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Creteil, France, 94010
        • Hôpital Henri Mondor
      • Lyon Cedex 02, France, 69288
        • CHU de Lyon, Hôpital de l'Hôtel Dieu
      • Marseille Cedex 08, France, 13285
        • Höpital Saint-Joseph
      • Orleans, France, 45100
        • Hôpital de la Source
      • Paris, France, 75012
        • Hôpital Saint-Antoine
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere
      • Pessac cedex, France, 33600
        • Hopital Haut-Leveque
      • 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
        • Universitätsklinikum Heidelberg
      • Leipzig, Germany, 4103
        • Universitatsklinikum 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,
      • Mumbai, India, 400 016
        • P. D. Hinduja National Hospital and Medical Research Centre
      • New Delhi, India, 110 002
        • Maulana Azad Medical College and Associated Lok Nayak 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
  • Korea, Republic of
      • Bundang, Korea, Republic of, 463-712
        • Bundang CHA hospital
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Pusan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Seonnam City, Korea, Republic of, 463-802
        • Seoul National University Hospital(Bundang)
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135-720
        • Yongdong Severance Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital(SVR)
      • Seoul, Korea, Republic of, 130-702
        • Kyunghee University - Medical center
      • Seoul, Korea, Republic of, 136-705
        • Korea University Medical Center(Anam)
      • Seoul, Korea, Republic of, 152-703
        • Korea University Medical Center(Guro)
      • Suwon, Korea, Republic of, 443-821
        • Aju University Hospital
  • Malaysia
      • Alor Setar, Malaysia, 5150
        • Hospital Alor Setar
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Malaysia, 50603
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia, 56000
        • HUKM
      • Selangor, Malaysia, 68100
        • Hospital Selayang
  • Mexico
      • Mexico City, Mexico, 11950
        • Clínica Lomas Altas
    • CP
      • Monterrey N.L., CP, Mexico, 64460
        • Hosp. Universitario. Monterrey
    • DF
      • Mexico, DF, Mexico, 14000
        • Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"
  • Poland
      • Bialystok, Poland, 15-540
        • Wojewodzki Szpital Specjalistyczny
      • Czeladz, Poland, 41-250
        • Niepubliczny Zaklad Opieki Zdrowotnej
      • Kielce, Poland, 25-317
        • Wojewodzki Szpital Zespolony
      • Krakow, Poland, 31-531
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Poland, 91-347
        • Uniwersytet Medyczny
      • Warszawa, Poland, 01-201
        • Wojewodzki Szpital Zakazny
      • Wroclaw, Poland, 50-220
        • Przychodnia przy Łowieckie
  • Puerto Rico
      • Santurce, Puerto Rico, 909
        • Fundacion De Investigacion de Diego
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 529889
        • CGH
  • 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 Marañón
      • Madrid, Spain, 28029
        • Hospital Carlos III
      • Sevilla, Spain, 41014
        • Complejo Hospitalario Nuestra Senora de Valme
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
  • Sweden
      • Malmö, Sweden, 205 02
        • Universitetssjukhuset MAS
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset
  • Taiwan
      • Changhua, Taiwan, 500
        • CCH
      • Taichung, Taiwan, 404
        • CMUH
      • Tainan, Taiwan, 704
        • NCKUH
      • Tainan, Taiwan, 710
        • CMMC
      • Taipei, Taiwan, 231
        • TCGH-TP
    • R.o.c.
      • Hualien, R.o.c., Taiwan, 970
        • TCGH-HL
      • Kaohsiung, R.o.c., Taiwan, 807
        • KMUH
      • Kaohsiung, R.o.c., Taiwan, 833
        • KCGMH
      • Taichung, R.o.c., Taiwan, 407
        • VGH-TC
      • Taipei, R.o.c., Taiwan, 100
        • NTUH
      • Taipei, R.o.c., Taiwan, 114
        • TSGH
      • Taoyuan, R.o.c., Taiwan, 333
        • CGMH-LK
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
  • United Kingdom
      • London, United Kingdom, E1 2AT
        • Barts and the London NHS Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Denver, Colorado, United States, 80262-0001
        • University of Colorado
    • 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, 33136-1051
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, United States, 30309
        • GI of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Center for Viral Hepatits
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, P.A.
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico
    • New York
      • Bronx, New York, United States, 10468
        • Bronx VA Medical Center
      • New York, New York, United States, 10021
        • New York Hospital - Cornell
      • New York, New York, United States, 10029
        • Faculty Practice Associates
      • New York, New York, United States, 10032
        • NY Presbyterian Medical Center - Columbia Univ. Med Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
        • University of North Carolina At Chapel Hill
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
        • Regional Gastroenterology Associates of Lancaster, Ltd.
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • San Antonio, Texas, United States, 78215
        • Alamo Medrical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research

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 2/3.
  • 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
Experimental: 1
900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Drug: albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
Drug: Ribavirin
800mg/day for 24 weeks
Experimental: 2
1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Drug: albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
Drug: Ribavirin
800mg/day for 24 weeks
Active Comparator: 3
180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
Drug: Ribavirin
800mg/day for 24 weeks
Drug: peginterferon alfa-2a
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virologic response (SVR)
Time Frame: Week 48
Week 48

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
Normalization of ALT (a liver enzyme)
Time Frame: Week 48
Week 48
Undetectable HCV RNA
Time Frame: Week 24
Week 24
Quality of life evaluation
Time Frame: Week 48
Week 48
Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)
Time Frame: Througout the entire treatment period
Througout the entire treatment period

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

February 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

December 13, 2006

First Submitted That Met QC Criteria

December 13, 2006

First Posted (Estimate)

December 14, 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-C1067
  • ACHIEVE-2/3

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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