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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Albuferon
Ribavirin
PEG-IFNalfa2a
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • John Hunter Hospital
  • Westmead Hospital
  • Princess Alexandra Hospital
  • Royal Brisbane Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • St. Vincents Hospital
  • Western Hospital
  • Austin Health
  • The Alfred
  • Royal Melbourne Hospital
  • Fremantle Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • University of Calgary
  • University of Alberta
  • University of Alberta- Liver Unit
  • University of British Columbia
  • University of Manitoba
  • Dalhousie University
  • McMaster Clinic - Hamilton General Hospital
  • University of Western Ontario
  • Ottawa Civic Hospital
  • Toronto General Hospital
  • Toronto Western Hospital
  • University of Saskatchewan
  • FN Bohunice
  • Klinika infekcnich nemoci
  • Nemocnice s poliklinikou Melnik
  • Slezska nemocnice
  • Vseobecna fakultni nemocnice
  • Nuselska poliklinika - Remedis
  • Fakultni Thomayerova nemocnice
  • Ambulance pro interni a infekcni nemoci
  • University of Angers, CHU Angers
  • University of Clichy, Hopital Beaujon
  • University of Creteil, Hopital Henri Mondor
  • University of Grenoble, Hopital Nord
  • University of Lille, Hopital Claude Huriez
  • University of Lyon, Hopital de l'Hotel Dieu
  • University of Marseille, Hopital Saint Joseph
  • University of Nice, Hopital de l'Archet
  • University of Orleans, Hopital de la Source
  • University of Paris, Hopital Saint-Antoine
  • University of Paris, Hopital Pitie-Salpetriere
  • University of Paris, Hopital Necker
  • Hopital Haut-Leveque
  • University of Toulouse, Clinique Dieulafoy
  • Hopital de Brabois
  • University of Berlin, Charite Campus Virchow Klinikum
  • University of Bochum, Kliniken Bergmannsheil
  • University of Duesseldorf
  • University of Essen
  • University of Frankfurt
  • University of Freiburg
  • University of Hamburg, Hospital Hamburg Eppendorf
  • University of Hannover
  • University of Heidelberg
  • University of Saarland
  • University of Kiel
  • University of Leipzig
  • University of Mainz
  • University of Tuebingen
  • B´nai-Zion Medical Center
  • Rambam Medical Center
  • Hadassah Medical Organization
  • Holy Family Hospital
  • Rabin Medical Center, Beilinson Campus
  • Tel Aviv Sourasky Medical Center
  • Oddzial Chorob Watroby
  • Katedra i Klinika Chorob Zakaznych i Hepatologii
  • Katedra i Oddzial Kliniczny Chorob Zakaznych
  • Wojewodzki Szpital Zespolony
  • Szpital Uniwersytecki w Krakowie
  • Klinika Obserwacyjno Zakazna
  • Oddzial Zakazny
  • Katedra i Klinika Chorob Zakaznych
  • I Oddzial Dzienny SPZOZ
  • Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
  • Katedra i Klinika Chorob Zakaznych
  • Spitalul Clinic Colentina
  • Institutul Clinic Fundeni
  • Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
  • Spitalul Clinic de Adulti Cluj-Napoca
  • Institutul de Gastroenterologie si Hepatologie

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2005
Last Updated
November 5, 2013
Sponsor
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00115908
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Albuferon
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Type
Drug
Intervention Name(s)
PEG-IFNalfa2a
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
Secondary Outcome Measure Information:
Title
Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Title
Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Title
Undetectable HCV RNA at Week 24.
Title
End of treatment response (ETR), defined as undetectable HCV RNA at Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St. Vincents Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
University of Alberta- Liver Unit
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
McMaster Clinic - Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Name
Ottawa Civic Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1S 0W8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
FN Bohunice
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Klinika infekcnich nemoci
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Nemocnice s poliklinikou Melnik
City
Melnik
ZIP/Postal Code
27601
Country
Czech Republic
Facility Name
Slezska nemocnice
City
Opava
ZIP/Postal Code
74601
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Nuselska poliklinika - Remedis
City
Prague
ZIP/Postal Code
14000
Country
Czech Republic
Facility Name
Fakultni Thomayerova nemocnice
City
Prague
ZIP/Postal Code
14059
Country
Czech Republic
Facility Name
Ambulance pro interni a infekcni nemoci
City
Usti nad labem
ZIP/Postal Code
40001
Country
Czech Republic
Facility Name
University of Angers, CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
University of Clichy, Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
University of Creteil, Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
University of Grenoble, Hopital Nord
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
University of Lille, Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University of Lyon, Hopital de l'Hotel Dieu
City
Lyon
ZIP/Postal Code
69288
Country
France
Facility Name
University of Marseille, Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
University of Nice, Hopital de l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
University of Orleans, Hopital de la Source
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
University of Paris, Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
University of Paris, Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
University of Paris, Hopital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hopital Haut-Leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
University of Toulouse, Clinique Dieulafoy
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital de Brabois
City
Vandoeuvre
ZIP/Postal Code
54511
Country
France
Facility Name
University of Berlin, Charite Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University of Bochum, Kliniken Bergmannsheil
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
University of Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40255
Country
Germany
Facility Name
University of Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
University of Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
University of Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
University of Hamburg, Hospital Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University of Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University of Saarland
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
University of Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
University of Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University of Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
B´nai-Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Holy Family Hospital
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Oddzial Chorob Watroby
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Katedra i Klinika Chorob Zakaznych i Hepatologii
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Katedra i Oddzial Kliniczny Chorob Zakaznych
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony
City
Kielce
ZIP/Postal Code
24-317
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Klinika Obserwacyjno Zakazna
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Oddzial Zakazny
City
Poznan
ZIP/Postal Code
61-003
Country
Poland
Facility Name
Katedra i Klinika Chorob Zakaznych
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
I Oddzial Dzienny SPZOZ
City
Warsaw
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
City
Warsaw
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Katedra i Klinika Chorob Zakaznych
City
Wroclaw
ZIP/Postal Code
51-149
Country
Poland
Facility Name
Spitalul Clinic Colentina
City
Bucharest
ZIP/Postal Code
20125
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
City
Bucharest
ZIP/Postal Code
30303
Country
Romania
Facility Name
Spitalul Clinic de Adulti Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400162
Country
Romania
Facility Name
Institutul de Gastroenterologie si Hepatologie
City
Iasi
ZIP/Postal Code
700111
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
19447518
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.
Results Reference
derived
PubMed Identifier
18666223
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.
Results Reference
derived

Learn more about this trial

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

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