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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
albumin interferon alfa-2b
peginterferon alfa-2a
Ribavirin
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, Hepatitis C, CHC, HepC, Genotype 1, Hepatitis, HCV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Hospital
  • UCSF Fresno
  • Scripps Clinic
  • USC Keck School of Medicine
  • Cedars-Sinai Medical Center
  • UCLA / West LA VAMC
  • Huntington Medical Research Institutes
  • University California-San Diego
  • San Diego Digestive Diseases Consultants, Inc
  • VA San Diego Healthcare
  • California Pacific Medical Center
  • University of California at San Francisco
  • University of Colorado
  • University of Colorado Health Sciences Ctr
  • Walter Reed Army Medical Center
  • University of Florida - Gainesville
  • Shands Jacksonville Medical Center
  • Mayo Clinic Transplant Center
  • Va Health Care System
  • University of Miami
  • Venture Research Institute
  • University Hepatitis Center
  • Atlanta Gastroenterology Associates
  • GI of Atlanta
  • Northwest Georgia Gastroenterology Associates
  • Alan D Tice, MD, LLC
  • Northwestern Memorial Hospital
  • Indiania University School of Medicine
  • University of Iowa Hospitals and Clinics
  • University of Louisville
  • Tulane University Health Sciences Center
  • University of Maryland
  • Johns Hopkins Center for Viral Hepatits
  • Maryland Digestive Disease Center
  • Beth Israel Deaconess Medical Center
  • Henry Ford Health System
  • Mayo Clinic
  • Digestive Health Specialist
  • St. Louis University
  • University of New Mexico
  • North Shore University Hospital
  • New York Hospital - Cornell
  • Faculty Practice Associates
  • University of North Carolina at Chapel Hill
  • Duke Medical Center
  • University of Cincinnati
  • Hospital of University of PA
  • Thomas Jefferson University
  • Memphis Gastroenterology Group
  • Nashville Gastroenterology
  • Nashville Gastrointestinal Specialists
  • Liver Institute at Methodist Dallas
  • Baylor University Medical Center
  • UT Southwesten Medical Center
  • Brooke Army Medical Center
  • GI & Liver Assoicates
  • Liver Specialist of Texas
  • Alamo Medical Research
  • INOVA Fairfax Hospital
  • Metropolitan Research
  • Virginia Commonwealth University Medical Ctr
  • University of Washington
  • University of Wisconsin-Madison
  • Medical College of Wisconsin
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • St George Hospital Clinical School of Medicine University of New South Wales
  • John Hunter Hospital
  • Westmead Hospital
  • Greenslopes Private Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • St Vincent's Hospital
  • Western Hospital
  • Austin Hospital
  • The Alfred Hospital
  • Royal Melbourne Hospital
  • Fremantle Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Medizinische Universitätsklinik Graz
  • Univ.-Klinik fuer Innere Medizin
  • Medical University of Vienna
  • Heritage Medical Research Clinic
  • University of Alberta
  • University of Alberta Hospital
  • Vancouver General Hospital
  • University of Manitoba Health Sciences Centre
  • Dalhousie University
  • University of Western Ontario Hospital
  • Ottawa Hospital - General Campus
  • Toronto General Hospital
  • Toronto Western Hospital
  • McGill University
  • Klinika infekcních chorob
  • Klinika Infekcních nemocí
  • Nemocnice s poliklinikou Melník
  • Slezská nemocnice
  • Vseobecna fakultní nemocnice
  • Nuselská poliklinika
  • Ambulance pro interni a infekcni nemoci
  • Hopital Beaujon
  • Hopital Henri Mondor
  • CHU de Lyon, Hôpital de l'Hôtel Dieu
  • Hopital Saint-Joseph
  • Hopital de La Source
  • Hôpital Saint-Antoine
  • Hopital Pitie-Salpetriere
  • Hopital Haut-Leveque
  • CHU Purpan Clinique Dieulafoy
  • Hôpital de Brabois
  • UH Charite Berlin / Virchow Klinikum
  • Universitätsklinik Düsseldorf
  • Center for HIV and Hepatogastroenterology
  • UH Essen
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Albert-Ludwigs-Universitaet Freiburg
  • Medizinische Hochschule Hannover (MHH)
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Leipzig
  • Johannes Gutenberg-Universitaet Mainz
  • Paracelsus Klinik der Stadt Marl
  • Dayanand Medical College and Hospital
  • Jaslok Hospital and Research Centre and Breach Candy Hospital,
  • G.B.Pant Hospital
  • Bnei-Zion Medical Center
  • Rambam Health Care Campus
  • Hadassah Medical Organization
  • Holy Family Hospital
  • Rabin Medical Center Beilinson Campus
  • Tel Aviv Sourasky Medical Center
  • Policlinico S.Orsola Malpighi
  • IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano
  • Seconda Università di Napoli c/o Secondo Policlinico
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia
  • Casa Sollievo della Sofferenza IRCCS
  • Azienda Ospedaliera S. Giovanni Battista Molinette
  • Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego
  • Szpital Specjalistyczny
  • Wojewódzki Szpital Zespolony
  • Szpital Uniwersytecki w Krakowie
  • Akademia Medyczna
  • Wojewódzki Szpital Zaka?ny
  • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
  • Uniwersytet Medyczny
  • Fundacion de Investigacion de Diego
  • Spitalul Clinic Colentina
  • Institutul Clinic Fundeni
  • Spitalul Clinic Dr.Victor Babes
  • Spitalul Clinic de Adulti Cluj-Napoca
  • Institutul de Gastroenterologie si Hepatologie
  • Hospital Universitari Germans Trias i Pujol
  • Hopital Universitari Vall d'Hebron
  • Hospital Clinic i Provincial
  • Hospital Universitario La Princesa
  • Hospital General Universitario Gregorio Marañón
  • Hospital Carlos III
  • Consorcio Hospital General Universitario de Valencia
  • Queen Elizabeth Medical Centre
  • Royal London Hospital
  • Imperial College London St Mary's Hospital Campus
  • Nottingham University Hospitals NHS Trust Queens Medical Centre Campus
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day

900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day

1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day

Outcomes

Primary Outcome Measures

Sustained virologic response (SVR)

Secondary Outcome Measures

Rapid virologic response
Early virologic response
Undetectable HCV RNA
Normalization of ALT (a liver enzyme)
Quality of life evaluation
Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing)

Full Information

First Posted
November 20, 2006
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00402428
Brief Title
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.
Collaborators
Novartis

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic Hepatitis C, Hepatitis C, CHC, HepC, Genotype 1, Hepatitis, HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
Arm Title
2
Arm Type
Experimental
Arm Description
900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Arm Title
3
Arm Type
Experimental
Arm Description
1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Intervention Type
Drug
Intervention Name(s)
albumin interferon alfa-2b
Intervention Description
900 mcg or 1200mcg every two week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a
Intervention Description
180 mcg once a week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg)
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR)
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
Rapid virologic response
Time Frame
Week 4
Title
Early virologic response
Time Frame
Week 12
Title
Undetectable HCV RNA
Time Frame
Week 24 and Week 48
Title
Normalization of ALT (a liver enzyme)
Time Frame
Week 48
Title
Quality of life evaluation
Time Frame
throughout the entire study
Title
Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing)
Time Frame
Throughout the entire study

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
16731032
Citation
Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naive patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. doi: 10.1016/j.hepres.2006.04.005. Epub 2006 May 30.
Results Reference
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PubMed Identifier
16487617
Citation
Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. doi: 10.1016/j.jhep.2005.12.011. Epub 2006 Jan 30.
Results Reference
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Citation
S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006
Results Reference
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Citation
Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006
Results Reference
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PubMed Identifier
16518958
Citation
Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45.
Results Reference
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PubMed Identifier
20600013
Citation
Zeuzem S, Sulkowski MS, Lawitz EJ, Rustgi VK, Rodriguez-Torres M, Bacon BR, Grigorescu M, Tice AD, Lurie Y, Cianciara J, Muir AJ, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-1 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 1. Gastroenterology. 2010 Oct;139(4):1257-66. doi: 10.1053/j.gastro.2010.06.066. Epub 2010 Jun 27.
Results Reference
derived

Learn more about this trial

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

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