Back to resultsEfficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
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
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
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.
Sites / Locations
- Mayo Clinic Hospital
- Scripps Clinic
- California Pacific Medical Center
- University of Colorado
- University of Florida-Gainesville
- Shands Jacksonville Medical Center
- Mayo Clinic Transplant Center
- University of Miami
- Atlanta Gastroenterology Associates
- GI of Atlanta
- University of Chicago Hospital
- Johns Hopkins Center for Viral Hepatits
- Beth Israel Deaconess Medical Center
- Minnesota Gastroenterology, P.A.
- Dartmouth Hitchcock Medical Center
- University of New Mexico
- Bronx VA Medical Center
- New York Hospital - Cornell
- Faculty Practice Associates
- NY Presbyterian Medical Center - Columbia Univ. Med Center
- University of North Carolina at Chapel Hill
- Regional Gastroenterology Associates of Lancaster, Ltd.
- Thomas Jefferson University
- Temple University Hospital
- Baylor University Medical Center
- Brooke Army Medical Center
- Alamo Medrical Research
- Metropolitan Research
- Unidad de Hepatología
- Fundación Cidea
- Hospital Italiano
- Hospital Universitario Austral
- Htal Pcial del Centenario
- Royal Prince Alfred Hospital
- Concord Repatriation General Hospital
- St George Hospital Clinical School of Medicine
- John Hunter Hospital
- Westmead Hospital
- Gallipoli Research Foundation and Greenslopes Private Hospital
- Royal Bribane & Women's Hospital
- Royal Adelaide Hospital
- Monash Medical Centre
- St Vincent's Hospital
- Western Hospital
- Austin Hospital
- The Alfred Hospital
- Royal Melbourne Hospital
- Fremantle Hospital
- CHU Brugmann ULB - site Victor Horta
- UCL
- University Hospital Antwerp
- Ghent University Hospital
- CHU Sart Tilman
- Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Universidade Federal de São Paulo - UNIFESP
- Hospital Heliópolis
- Hospital das Clínicas da Faculdade de Medicina da USP
- Heritage Medical Research Clinic
- University of Alberta
- University of Alberta Hospital
- Vancouver General Hospital
- University of Manitoba Health Sciences Centre
- University of Western Ontario Hospital
- Ottawa Hospital - General Campus
- Toronto General Hospital
- Toronto Western Hospital
- McGill University
- 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,
- P. D. Hinduja National Hospital and Medical Research Centre
- G.B.Pant Hospital
- Maulana Azad Medical College and Associated Lok Nayak 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
- Bundang CHA Hospital
- Kyungpook National University Hospital
- Pusan National University Hospital
- Seoul National University Hospital(Bundang)
- Severance Hospital(SVR)
- Kyunghee University - Medical center
- Samsung Medical Center
- Yongdong Severance Hospital
- Korea University Medical Center(Anam)
- Asan Medical Center
- Korea University Medical Center(Guro)
- Aju University Hospital
- Hospital Alor Setar
- Hospital Kuala Lumpur
- University Malaya Medical Centre
- HUKM
- Hospital Selayang
- Hosp. Universitario. Monterrey
- Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"
- Clínica Lomas Altas
- Wojewódzki Szpital Specjalistyczny
- Niepubliczny Zaklad Opieki Zdrowotnej
- Wojewódzki Szpital Zespolony
- Szpital Uniwersytecki w Krakowie
- Uniwersytet Medyczny
- Wojewódzki Szpital Zakaźny
- Przychodnia przy Łowieckie
- Fundacion de Investigacion de Diego
- National University Hospital
- Singapore General Hospital
- Tan Tock Seng Hospital
- CGH
- 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
- Complejo Hospitalario Nuestra Señora de Valme
- Consorcio Hospital General Universitario de Valencia
- Universitetssjukhuset MAS
- Karolinska Universitetssjukhuset
- TCGH-HL
- KMUH
- KCGMH
- VGH-TC
- NTUH
- TSGH
- CGMH-LK
- CCH
- CMUH
- NCKUH
- CMMC
- TCGH-TP
- Chulalongkorn Hospital
- Ramathibodi Hospital
- Siriraj Hospital
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
- Barts and the London NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per 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 results)
Full Information
NCT ID
NCT00411385
First Posted
December 13, 2006
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00411385
Brief Title
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (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 2/3 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
933 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Arm Title
2
Arm Type
Experimental
Arm Description
1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Arm Title
3
Arm Type
Active Comparator
Arm Description
180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
Intervention Type
Drug
Intervention Name(s)
albumin interferon alfa-2b
Intervention Description
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a
Intervention Description
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
800mg/day for 24 weeks
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR)
Time Frame
Week 48
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
Title
Normalization of ALT (a liver enzyme)
Time Frame
Week 48
Title
Quality of life evaluation
Time Frame
Week 48
Title
Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)
Time Frame
Througout the entire treatment period
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 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.
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
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
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 Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262-0001
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
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1051
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
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
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
Bronx VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
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
NY Presbyterian Medical Center - Columbia Univ. Med Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
Regional Gastroenterology Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604-3200
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
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
Alamo Medrical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Unidad de Hepatología
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Fundación Cidea
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Hospital Italiano
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Facility Name
Htal Pcial del Centenario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
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
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
Gallipoli Research Foundation and Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal Bribane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
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
CHU Brugmann ULB - site Victor Horta
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
UCL
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Ghent University Hospital
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
City
Salvador
State/Province
BA
ZIP/Postal Code
40110-170
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14049-900
Country
Brazil
Facility Name
Universidade Federal de São Paulo - UNIFESP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
Facility Name
Hospital Heliópolis
City
São Paulo
State/Province
SP
ZIP/Postal Code
04230-000
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
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
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
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
P. D. Hinduja National Hospital and Medical Research Centre
City
Mumbai
ZIP/Postal Code
400 016
Country
India
Facility Name
G.B.Pant Hospital
City
New Delhi
ZIP/Postal Code
110 002
Country
India
Facility Name
Maulana Azad Medical College and Associated Lok Nayak 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
Bundang CHA Hospital
City
Bundang
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Seoul National University Hospital(Bundang)
City
Seonnam City
ZIP/Postal Code
463-802
Country
Korea, Republic of
Facility Name
Severance Hospital(SVR)
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Kyunghee University - Medical center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Yongdong Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Korea University Medical Center(Anam)
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea University Medical Center(Guro)
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Aju University Hospital
City
Suwon
ZIP/Postal Code
443-821
Country
Korea, Republic of
Facility Name
Hospital Alor Setar
City
Alor Setar
ZIP/Postal Code
5150
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
HUKM
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Hospital Selayang
City
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hosp. Universitario. Monterrey
City
Monterrey N.L.
State/Province
CP
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"
City
Mexico
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Clínica Lomas Altas
City
Mexico City
ZIP/Postal Code
11950
Country
Mexico
Facility Name
Wojewódzki Szpital Specjalistyczny
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
Facility Name
Wojewódzki Szpital Zespolony
City
Kielce
ZIP/Postal Code
25-317
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Uniwersytet Medyczny
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Wojewódzki Szpital Zakaźny
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Przychodnia przy Łowieckie
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Fundacion de Investigacion de Diego
City
Santurce
ZIP/Postal Code
909
Country
Puerto Rico
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
CGH
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
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
Complejo Hospitalario Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Universitetssjukhuset MAS
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
TCGH-HL
City
Hualien
State/Province
R.o.c.
ZIP/Postal Code
970
Country
Taiwan
Facility Name
KMUH
City
Kaohsiung
State/Province
R.o.c.
ZIP/Postal Code
807
Country
Taiwan
Facility Name
KCGMH
City
Kaohsiung
State/Province
R.o.c.
ZIP/Postal Code
833
Country
Taiwan
Facility Name
VGH-TC
City
Taichung
State/Province
R.o.c.
ZIP/Postal Code
407
Country
Taiwan
Facility Name
NTUH
City
Taipei
State/Province
R.o.c.
ZIP/Postal Code
100
Country
Taiwan
Facility Name
TSGH
City
Taipei
State/Province
R.o.c.
ZIP/Postal Code
114
Country
Taiwan
Facility Name
CGMH-LK
City
Taoyuan
State/Province
R.o.c.
ZIP/Postal Code
333
Country
Taiwan
Facility Name
CCH
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
CMUH
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
NCKUH
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
CMMC
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
TCGH-TP
City
Taipei
ZIP/Postal Code
231
Country
Taiwan
Facility Name
Chulalongkorn Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
E1 2AT
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
background
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
background
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
background
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
background
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
background
PubMed Identifier
20600017
Citation
Nelson DR, Benhamou Y, Chuang WL, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JW, Kryczka W, Lee CM, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-2/3 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3. Gastroenterology. 2010 Oct;139(4):1267-76. doi: 10.1053/j.gastro.2010.06.062. Epub 2010 Jul 1.
Results Reference
derived
Learn more about this trial
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
We'll reach out to this number within 24 hrs