A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115908
• Other study ID #: ALFR-HC-04
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2005
• Last updated: November 5, 2013
• Start date: May 2005
• Est. completion date: May 2007

Study information

• Verified date: November 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of HealthRomania: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Albuferon

• Ribavirin

• PEG-IFNalfa2a

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St. Vincents Hospital	East Melbourne	Victoria
Australia	Western Hospital	Footscray	Victoria
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Austin Health	Heidelberg	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	The Alfred	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	John Hunter Hospital	New Lambton Heights	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Westmead Hospital	Westmead	New South Wales
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Alberta- Liver Unit	Edmonton	Alberta
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	McMaster Clinic - Hamilton General Hospital	Hamilton	Ontario
Canada	University of Western Ontario	London	Ontario
Canada	Ottawa Civic Hospital	Ottawa	Ontario
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
Czech Republic	FN Bohunice	Brno
Czech Republic	Klinika infekcnich nemoci	Hradec Kralove
Czech Republic	Nemocnice s poliklinikou Melnik	Melnik
Czech Republic	Slezska nemocnice	Opava
Czech Republic	Fakultni Thomayerova nemocnice	Prague
Czech Republic	Nuselska poliklinika - Remedis	Prague
Czech Republic	Vseobecna fakultni nemocnice	Prague
Czech Republic	Ambulance pro interni a infekcni nemoci	Usti nad labem
France	University of Angers, CHU Angers	Angers
France	University of Clichy, Hopital Beaujon	Clichy
France	University of Creteil, Hopital Henri Mondor	Creteil
France	University of Grenoble, Hopital Nord	Grenoble
France	University of Lille, Hopital Claude Huriez	Lille
France	University of Lyon, Hopital de l'Hotel Dieu	Lyon
France	University of Marseille, Hopital Saint Joseph	Marseille
France	University of Nice, Hopital de l'Archet	Nice
France	University of Orleans, Hopital de la Source	Orleans
France	University of Paris, Hopital Necker	Paris
France	University of Paris, Hopital Pitie-Salpetriere	Paris
France	University of Paris, Hopital Saint-Antoine	Paris
France	Hopital Haut-Leveque	Pessac
France	University of Toulouse, Clinique Dieulafoy	Toulouse
France	Hopital de Brabois	Vandoeuvre
Germany	University of Berlin, Charite Campus Virchow Klinikum	Berlin
Germany	University of Bochum, Kliniken Bergmannsheil	Bochum
Germany	University of Duesseldorf	Duesseldorf
Germany	University of Essen	Essen
Germany	University of Frankfurt	Frankfurt
Germany	University of Freiburg	Freiburg
Germany	University of Hamburg, Hospital Hamburg Eppendorf	Hamburg
Germany	University of Hannover	Hannover
Germany	University of Heidelberg	Heidelberg
Germany	University of Saarland	Homburg
Germany	University of Kiel	Kiel
Germany	University of Leipzig	Leipzig
Germany	University of Mainz	Mainz
Germany	University of Tuebingen	Tuebingen
Israel	B´nai-Zion Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Organization	Jerusalem
Israel	Holy Family Hospital	Nazareth
Israel	Rabin Medical Center, Beilinson Campus	Petah Tiqwa
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Poland	Oddzial Chorob Watroby	Bialystok
Poland	Katedra i Klinika Chorob Zakaznych i Hepatologii	Bydgoszcz
Poland	Katedra i Oddzial Kliniczny Chorob Zakaznych	Chorzow
Poland	Wojewodzki Szpital Zespolony	Kielce
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Klinika Obserwacyjno Zakazna	Lodz
Poland	Oddzial Zakazny	Poznan
Poland	Katedra i Klinika Chorob Zakaznych	Szczecin
Poland	I Oddzial Dzienny SPZOZ	Warsaw
Poland	Klinika Hepatologii i Nabytych Niedoborow Immunologicznych	Warsaw
Poland	Katedra i Klinika Chorob Zakaznych	Wroclaw
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Spitalul Clinic Colentina	Bucharest
Romania	Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"	Bucharest
Romania	Spitalul Clinic de Adulti Cluj-Napoca	Cluj-Napoca
Romania	Institutul de Gastroenterologie si Hepatologie	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  France,  Germany,  Israel,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
Secondary	Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Secondary	Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Secondary	Undetectable HCV RNA at Week 24.
Secondary	End of treatment response (ETR), defined as undetectable HCV RNA at Week 48