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

November 5, 2013 updated by: Human Genome Sciences Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

458

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • New Lambton Heights, New South Wales, Australia, 2305
        • John Hunter Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • East Melbourne, Victoria, Australia, 3002
        • St. Vincents Hospital
      • Footscray, Victoria, Australia, 3011
        • Western Hospital
      • Heidelberg, Victoria, Australia, 3081
        • Austin Health
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T5H 4B9
        • University of Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta- Liver Unit
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z4
        • University of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • University of Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y9
        • Dalhousie University
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • McMaster Clinic - Hamilton General Hospital
      • London, Ontario, Canada, N6A5A5
        • University of Western Ontario
      • Ottawa, Ontario, Canada, K1S 0W8
        • Ottawa Civic Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • University of Saskatchewan
  • Czech Republic
      • Brno, Czech Republic, 62500
        • FN Bohunice
      • Hradec Kralove, Czech Republic, 50005
        • Klinika Infekcních nemocí
      • Melnik, Czech Republic, 27601
        • Nemocnice s poliklinikou Melník
      • Opava, Czech Republic, 74601
        • Slezská nemocnice
      • Prague, Czech Republic, 12808
        • Vseobecna fakultni nemocnice
      • Prague, Czech Republic, 14000
        • Nuselska poliklinika - Remedis
      • Prague, Czech Republic, 14059
        • Fakultni Thomayerova nemocnice
      • Usti nad labem, Czech Republic, 40001
        • Ambulance pro interni a infekcni nemoci
  • France
      • Angers, France, 49033
        • University of Angers, CHU Angers
      • Clichy, France, 92110
        • University of Clichy, Hopital Beaujon
      • Creteil, France, 94010
        • University of Creteil, Hopital Henri Mondor
      • Grenoble, France, 38043
        • University of Grenoble, Hopital Nord
      • Lille, France, 59037
        • University of Lille, Hopital Claude Huriez
      • Lyon, France, 69288
        • University of Lyon, Hopital de l'Hotel Dieu
      • Marseille, France, 13285
        • University of Marseille, Hopital Saint Joseph
      • Nice, France, 06202
        • University of Nice, Hopital de l'Archet
      • Orleans, France, 45100
        • University of Orleans, Hopital de la Source
      • Paris, France, 75012
        • University of Paris, Hopital Saint-Antoine
      • Paris, France, 75013
        • University of Paris, Hopital Pitie-Salpetriere
      • Paris, France, 75743
        • University of Paris, Hopital Necker
      • Pessac, France, 33600
        • Hopital Haut-Lévêque
      • Toulouse, France, 31059
        • University of Toulouse, Clinique Dieulafoy
      • Vandoeuvre, France, 54511
        • Hôpital de Brabois
  • Germany
      • Berlin, Germany, 13353
        • University of Berlin, Charite Campus Virchow Klinikum
      • Bochum, Germany, 44892
        • University of Bochum, Kliniken Bergmannsheil
      • Duesseldorf, Germany, 40255
        • University of Duesseldorf
      • Essen, Germany, 45122
        • University of Essen
      • Frankfurt, Germany, 60590
        • University of Frankfurt
      • Freiburg, Germany, 79106
        • University of Freiburg
      • Hamburg, Germany, 20246
        • University of Hamburg, Hospital Hamburg Eppendorf
      • Hannover, Germany, 30625
        • University of Hannover
      • Heidelberg, Germany, 69120
        • University of Heidelberg
      • Homburg, Germany, 66421
        • University of Saarland
      • Kiel, Germany, 24105
        • University of Kiel
      • Leipzig, Germany, 04103
        • University of Leipzig
      • Mainz, Germany, 55131
        • University of Mainz
      • Tuebingen, Germany, 72076
        • University of Tuebingen
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Haifa, Israel, 31048
        • B´nai-Zion Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization
      • Nazareth, Israel, 16100
        • Holy Family Hospital
      • Petah Tiqwa, Israel, 49100
        • Rabin Medical Center, Beilinson campus
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Poland
      • Bialystok, Poland, 15-540
        • Oddzial Chorob Watroby
      • Bydgoszcz, Poland, 85-030
        • Katedra i Klinika Chorob Zakaznych i Hepatologii
      • Chorzow, Poland, 41-500
        • Katedra i Oddzial Kliniczny Chorob Zakaznych
      • Kielce, Poland, 24-317
        • Wojewodzki Szpital Zespolony
      • Krakow, Poland, 31-531
        • Szpital Uniwersytecki W Krakowie
      • Lodz, Poland, 91-347
        • Klinika Obserwacyjno Zakazna
      • Poznan, Poland, 61-003
        • Oddzial Zakazny
      • Szczecin, Poland, 71-455
        • Katedra i Klinika Chorob Zakaznych
      • Warsaw, Poland, 01-201
        • I Oddzial Dzienny SPZOZ
      • Warsaw, Poland, 01-201
        • Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
      • Wroclaw, Poland, 51-149
        • Katedra i Klinika Chorob Zakaznych
  • Romania
      • Bucharest, Romania, 20125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 22328
        • Institutul Clinic Fundeni
      • Bucharest, Romania, 30303
        • Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
      • Cluj-Napoca, Romania, 400162
        • Spitalul Clinic de Adulti Cluj-Napoca
      • Iasi, Romania, 700111
        • Institutul de Gastroenterologie si Hepatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Genome Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 26, 2005

First Submitted That Met QC Criteria

June 29, 2005

First Posted (Estimate)

June 27, 2005

Study Record Updates

Last Update Posted (Estimate)

November 7, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFR-HC-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C, Chronic

Clinical Trials on Ribavirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe