Clinical trial NCT00115908: A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2005-06-27
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
* Compensated liver disease

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
Secondary outcomes:
measure: Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
measure: Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
measure: Undetectable HCV RNA at Week 24.
measure: End of treatment response (ETR), defined as undetectable HCV RNA at Week 48
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: East Melbourne
country: Australia
facility: St. Vincents Hospital
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta- Liver Unit
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Clinic - Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Civic Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Brno
country: Czech Republic
facility: FN Bohunice
city: Hradec Kralove
country: Czech Republic
facility: Klinika infekcnich nemoci
city: Melnik
country: Czech Republic
facility: Nemocnice s poliklinikou Melnik
city: Opava
country: Czech Republic
facility: Slezska nemocnice
city: Prague
country: Czech Republic
facility: Vseobecna fakultni nemocnice
city: Prague
country: Czech Republic
facility: Nuselska poliklinika - Remedis
city: Prague
country: Czech Republic
facility: Fakultni Thomayerova nemocnice
city: Usti nad labem
country: Czech Republic
facility: Ambulance pro interni a infekcni nemoci
city: Angers
country: France
facility: University of Angers, CHU Angers
city: Clichy
country: France
facility: University of Clichy, Hopital Beaujon
city: Creteil
country: France
facility: University of Creteil, Hopital Henri Mondor
city: Grenoble
country: France
facility: University of Grenoble, Hopital Nord
city: Lille
country: France
facility: University of Lille, Hopital Claude Huriez
city: Lyon
country: France
facility: University of Lyon, Hopital de l'Hotel Dieu
city: Marseille
country: France
facility: University of Marseille, Hopital Saint Joseph
city: Nice
country: France
facility: University of Nice, Hopital de l'Archet
city: Orleans
country: France
facility: University of Orleans, Hopital de la Source
city: Paris
country: France
facility: University of Paris, Hopital Saint-Antoine
city: Paris
country: France
facility: University of Paris, Hopital Pitie-Salpetriere
city: Paris
country: France
facility: University of Paris, Hopital Necker
city: Pessac
country: France
facility: Hopital Haut-Leveque
city: Toulouse
country: France
facility: University of Toulouse, Clinique Dieulafoy
city: Vandoeuvre
country: France
facility: Hopital de Brabois
city: Berlin
country: Germany
facility: University of Berlin, Charite Campus Virchow Klinikum
city: Bochum
country: Germany
facility: University of Bochum, Kliniken Bergmannsheil
city: Duesseldorf
country: Germany
facility: University of Duesseldorf
city: Essen
country: Germany
facility: University of Essen
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Freiburg
country: Germany
facility: University of Freiburg
city: Hamburg
country: Germany
facility: University of Hamburg, Hospital Hamburg Eppendorf
city: Hannover
country: Germany
facility: University of Hannover
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Homburg
country: Germany
facility: University of Saarland
city: Kiel
country: Germany
facility: University of Kiel
city: Leipzig
country: Germany
facility: University of Leipzig
city: Mainz
country: Germany
facility: University of Mainz
city: Tuebingen
country: Germany
facility: University of Tuebingen
city: Haifa
country: Israel
facility: B´nai-Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center, Beilinson Campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bialystok
country: Poland
facility: Oddzial Chorob Watroby
city: Bydgoszcz
country: Poland
facility: Katedra i Klinika Chorob Zakaznych i Hepatologii
city: Chorzow
country: Poland
facility: Katedra i Oddzial Kliniczny Chorob Zakaznych
city: Kielce
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Klinika Obserwacyjno Zakazna
city: Poznan
country: Poland
facility: Oddzial Zakazny
city: Szczecin
country: Poland
facility: Katedra i Klinika Chorob Zakaznych
city: Warsaw
country: Poland
facility: I Oddzial Dzienny SPZOZ
city: Warsaw
country: Poland
facility: Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
city: Wroclaw
country: Poland
facility: Katedra i Klinika Chorob Zakaznych
city: Bucharest
country: Romania
facility: Spitalul Clinic Colentina
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucharest
country: Romania
facility: Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Adulti Cluj-Napoca
city: Iasi
country: Romania
facility: Institutul de Gastroenterologie si Hepatologie
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Zeuzem 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.