A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
1 other identifier
interventional
458
8 countries
87
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2005
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 26, 2005
CompletedFirst Posted
Study publicly available on registry
June 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 7, 2013
November 1, 2013
2 years
June 26, 2005
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
Secondary Outcomes (4)
Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Undetectable HCV RNA at Week 24.
End of treatment response (ETR), defined as undetectable HCV RNA at Week 48
Interventions
Eligibility Criteria
You may qualify if:
- Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
- Compensated liver disease
You may not qualify if:
- Pregnant or lactating female or males with a pregnant partner.
- A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
- A history of moderate, severe or uncontrolled psychiatric disease.
- A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
St. Vincents Hospital
East Melbourne, Victoria, 3002, Australia
Western Hospital
Footscray, Victoria, 3011, Australia
Austin Health
Heidelberg, Victoria, 3081, Australia
The Alfred
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of Alberta
Edmonton, Alberta, T5H 4B9, Canada
University of Alberta- Liver Unit
Edmonton, Alberta, T6G 2C8, Canada
University of British Columbia
Vancouver, British Columbia, V6T 1Z4, Canada
University of Manitoba
Winnipeg, Manitoba, R3E 3P4, Canada
Dalhousie University
Halifax, Nova Scotia, B3H2Y9, Canada
McMaster Clinic - Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
University of Western Ontario
London, Ontario, N6A5A5, Canada
Ottawa Civic Hospital
Ottawa, Ontario, K1S 0W8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
FN Bohunice
Brno, 62500, Czechia
Klinika infekcnich nemoci
Hradec Králové, 50005, Czechia
Nemocnice s poliklinikou Melnik
Mělník, 27601, Czechia
Slezska nemocnice
Opava, 74601, Czechia
Vseobecna fakultni nemocnice
Prague, 12808, Czechia
Nuselska poliklinika - Remedis
Prague, 14000, Czechia
Fakultni Thomayerova nemocnice
Prague, 14059, Czechia
Ambulance pro interni a infekcni nemoci
Ústí nad Labem, 40001, Czechia
University of Angers, CHU Angers
Angers, 49033, France
University of Clichy, Hopital Beaujon
Clichy, 92110, France
University of Creteil, Hopital Henri Mondor
Créteil, 94010, France
University of Grenoble, Hopital Nord
Grenoble, 38043, France
University of Lille, Hopital Claude Huriez
Lille, 59037, France
University of Lyon, Hopital de l'Hotel Dieu
Lyon, 69288, France
University of Marseille, Hopital Saint Joseph
Marseille, 13285, France
University of Nice, Hopital de l'Archet
Nice, 06202, France
University of Orleans, Hopital de la Source
Orléans, 45100, France
University of Paris, Hopital Saint-Antoine
Paris, 75012, France
University of Paris, Hopital Pitie-Salpetriere
Paris, 75013, France
University of Paris, Hopital Necker
Paris, 75743, France
Hopital Haut-Leveque
Pessac, 33600, France
University of Toulouse, Clinique Dieulafoy
Toulouse, 31059, France
Hopital de Brabois
Vandœuvre-lès-Nancy, 54511, France
University of Berlin, Charite Campus Virchow Klinikum
Berlin, 13353, Germany
University of Bochum, Kliniken Bergmannsheil
Bochum, 44892, Germany
University of Duesseldorf
Düsseldorf, 40255, Germany
University of Essen
Essen, 45122, Germany
University of Frankfurt
Frankfurt, 60590, Germany
University of Freiburg
Freiburg im Breisgau, 79106, Germany
University of Hamburg, Hospital Hamburg Eppendorf
Hamburg, 20246, Germany
University of Hannover
Hanover, 30625, Germany
University of Heidelberg
Heidelberg, 69120, Germany
University of Saarland
Homburg, 66421, Germany
University of Kiel
Kiel, 24105, Germany
University of Leipzig
Leipzig, 04103, Germany
University of Mainz
Mainz, 55131, Germany
University of Tuebingen
Tübingen, 72076, Germany
B´nai-Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 31096, Israel
Hadassah Medical Organization
Jerusalem, 91120, Israel
Holy Family Hospital
Nazareth, 16100, Israel
Rabin Medical Center, Beilinson Campus
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Oddzial Chorob Watroby
Bialystok, 15-540, Poland
Katedra i Klinika Chorob Zakaznych i Hepatologii
Bydgoszcz, 85-030, Poland
Katedra i Oddzial Kliniczny Chorob Zakaznych
Chorzów, 41-500, Poland
Wojewodzki Szpital Zespolony
Kielce, 24-317, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-531, Poland
Klinika Obserwacyjno Zakazna
Lodz, 91-347, Poland
Oddzial Zakazny
Poznan, 61-003, Poland
Katedra i Klinika Chorob Zakaznych
Szczecin, 71-455, Poland
I Oddzial Dzienny SPZOZ
Warsaw, 01-201, Poland
Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
Warsaw, 01-201, Poland
Katedra i Klinika Chorob Zakaznych
Wroclaw, 51-149, Poland
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Institutul Clinic Fundeni
Bucharest, 22328, Romania
Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
Bucharest, 30303, Romania
Spitalul Clinic de Adulti Cluj-Napoca
Cluj-Napoca, 400162, Romania
Institutul de Gastroenterologie si Hepatologie
Iași, 700111, Romania
Related Publications (2)
Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naive patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11.
PMID: 19447518DERIVEDZeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403.
PMID: 18666223DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2005
First Posted
June 27, 2005
Study Start
May 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
November 7, 2013
Record last verified: 2013-11