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

Information source: Human Genome Sciences Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Albuferon (Drug); Ribavirin (Drug); PEG-IFNalfa2a (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Human Genome Sciences Inc.

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Primary outcome: Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

FN Bohunice, Brno 62500, Czech Republic

Klinika infekcnich nemoci, Hradec Kralove 50005, Czech Republic

Nemocnice s poliklinikou Melnik, Melnik 27601, Czech Republic

Slezska nemocnice, Opava 74601, Czech Republic

Fakultni Thomayerova nemocnice, Prague 14059, Czech Republic

Nuselska poliklinika - Remedis, Prague 14000, Czech Republic

Vseobecna fakultni nemocnice, Prague 12808, Czech Republic

Ambulance pro interni a infekcni nemoci, Usti nad labem 40001, Czech Republic

University of Angers, CHU Angers, Angers 49033, France

University of Clichy, Hopital Beaujon, Clichy 92110, France

University of Creteil, Hopital Henri Mondor, Creteil 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, Orleans 45100, France

University of Paris, Hopital Necker, Paris 75743, France

University of Paris, Hopital Pitie-Salpetriere, Paris 75013, France

University of Paris, Hopital Saint-Antoine, Paris 75012, France

Hopital Haut-Leveque, Pessac 33600, France

University of Toulouse, Clinique Dieulafoy, Toulouse 31059, France

Hopital de Brabois, Vandoeuvre 54511, France

University of Berlin, Charite Campus Virchow Klinikum, Berlin 13353, Germany

University of Bochum, Kliniken Bergmannsheil, Bochum 44892, Germany

University of Duesseldorf, Duesseldorf 40255, Germany

University of Essen, Essen 45122, Germany

University of Frankfurt, Frankfurt 60590, Germany

University of Freiburg, Freiburg 79106, Germany

University of Hamburg, Hospital Hamburg Eppendorf, Hamburg 20246, Germany

University of Hannover, Hannover 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, Tuebingen 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 Tiqwa 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, Chorzow 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

Institutul Clinic Fundeni, Bucharest 22328, Romania

Spitalul Clinic Colentina, Bucharest 20125, 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, Iasi 700111, Romania

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

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

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

Princess Alexandra Hospital, Brisbane, Queensland 4102, Australia

Royal Brisbane Hospital, Herston, Queensland 4029, Australia

University of Saskatchewan, Saskatoon, Saskatchewan S7N 0W8, Canada

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

Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia

The Alfred, Melbourne, Victoria 3004, 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

Additional Information

Starting date: May 2005
Last updated: November 5, 2013

Page last updated: August 23, 2015

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