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

Sponsor

Human Genome Sciences Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00115908

Collaborator

(none)

458

Enrollment

Locations

Duration (Months)

5.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: Albuferon Drug: Ribavirin Drug: PEG-IFNalfa2a	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

458 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
2	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
3	John Hunter Hospital	New Lambton Heights	New South Wales	Australia	2305
4	Westmead Hospital	Westmead	New South Wales	Australia	2145
5	Princess Alexandra Hospital	Brisbane	Queensland	Australia	4102
6	Royal Brisbane Hospital	Herston	Queensland	Australia	4029
7	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
8	Monash Medical Centre	Clayton	Victoria	Australia	3168
9	St. Vincents Hospital	East Melbourne	Victoria	Australia	3002
10	Western Hospital	Footscray	Victoria	Australia	3011
11	Austin Health	Heidelberg	Victoria	Australia	3081
12	The Alfred	Melbourne	Victoria	Australia	3004
13	Royal Melbourne Hospital	Melbourne	Victoria	Australia	3050
14	Fremantle Hospital	Fremantle	Western Australia	Australia	6160
15	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
16	Royal Perth Hospital	Perth	Western Australia	Australia	6000
17	University of Calgary	Calgary	Alberta	Canada	T2N 4N1
18	University of Alberta	Edmonton	Alberta	Canada	T5H 4B9
19	University of Alberta- Liver Unit	Edmonton	Alberta	Canada	T6G 2C8
20	University of British Columbia	Vancouver	British Columbia	Canada	V6T 1Z4
21	University of Manitoba	Winnipeg	Manitoba	Canada	R3E 3P4
22	Dalhousie University	Halifax	Nova Scotia	Canada	B3H2Y9
23	McMaster Clinic - Hamilton General Hospital	Hamilton	Ontario	Canada	L8L 2X2
24	University of Western Ontario	London	Ontario	Canada	N6A5A5
25	Ottawa Civic Hospital	Ottawa	Ontario	Canada	K1S 0W8
26	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
27	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
28	University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 0W8
29	FN Bohunice	Brno		Czech Republic	62500
30	Klinika infekcnich nemoci	Hradec Kralove		Czech Republic	50005
31	Nemocnice s poliklinikou Melnik	Melnik		Czech Republic	27601
32	Slezska nemocnice	Opava		Czech Republic	74601
33	Vseobecna fakultni nemocnice	Prague		Czech Republic	12808
34	Nuselska poliklinika - Remedis	Prague		Czech Republic	14000
35	Fakultni Thomayerova nemocnice	Prague		Czech Republic	14059
36	Ambulance pro interni a infekcni nemoci	Usti nad labem		Czech Republic	40001
37	University of Angers, CHU Angers	Angers		France	49033
38	University of Clichy, Hopital Beaujon	Clichy		France	92110
39	University of Creteil, Hopital Henri Mondor	Creteil		France	94010
40	University of Grenoble, Hopital Nord	Grenoble		France	38043
41	University of Lille, Hopital Claude Huriez	Lille		France	59037
42	University of Lyon, Hopital de l'Hotel Dieu	Lyon		France	69288
43	University of Marseille, Hopital Saint Joseph	Marseille		France	13285
44	University of Nice, Hopital de l'Archet	Nice		France	06202
45	University of Orleans, Hopital de la Source	Orleans		France	45100
46	University of Paris, Hopital Saint-Antoine	Paris		France	75012
47	University of Paris, Hopital Pitie-Salpetriere	Paris		France	75013
48	University of Paris, Hopital Necker	Paris		France	75743
49	Hopital Haut-Leveque	Pessac		France	33600
50	University of Toulouse, Clinique Dieulafoy	Toulouse		France	31059
51	Hopital de Brabois	Vandoeuvre		France	54511
52	University of Berlin, Charite Campus Virchow Klinikum	Berlin		Germany	13353
53	University of Bochum, Kliniken Bergmannsheil	Bochum		Germany	44892
54	University of Duesseldorf	Duesseldorf		Germany	40255
55	University of Essen	Essen		Germany	45122
56	University of Frankfurt	Frankfurt		Germany	60590
57	University of Freiburg	Freiburg		Germany	79106
58	University of Hamburg, Hospital Hamburg Eppendorf	Hamburg		Germany	20246
59	University of Hannover	Hannover		Germany	30625
60	University of Heidelberg	Heidelberg		Germany	69120
61	University of Saarland	Homburg		Germany	66421
62	University of Kiel	Kiel		Germany	24105
63	University of Leipzig	Leipzig		Germany	04103
64	University of Mainz	Mainz		Germany	55131
65	University of Tuebingen	Tuebingen		Germany	72076
66	B´nai-Zion Medical Center	Haifa		Israel	31048
67	Rambam Medical Center	Haifa		Israel	31096
68	Hadassah Medical Organization	Jerusalem		Israel	91120
69	Holy Family Hospital	Nazareth		Israel	16100
70	Rabin Medical Center, Beilinson Campus	Petah Tiqwa		Israel	49100
71	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239
72	Oddzial Chorob Watroby	Bialystok		Poland	15-540
73	Katedra i Klinika Chorob Zakaznych i Hepatologii	Bydgoszcz		Poland	85-030
74	Katedra i Oddzial Kliniczny Chorob Zakaznych	Chorzow		Poland	41-500
75	Wojewodzki Szpital Zespolony	Kielce		Poland	24-317
76	Szpital Uniwersytecki w Krakowie	Krakow		Poland	31-531
77	Klinika Obserwacyjno Zakazna	Lodz		Poland	91-347
78	Oddzial Zakazny	Poznan		Poland	61-003
79	Katedra i Klinika Chorob Zakaznych	Szczecin		Poland	71-455
80	I Oddzial Dzienny SPZOZ	Warsaw		Poland	01-201
81	Klinika Hepatologii i Nabytych Niedoborow Immunologicznych	Warsaw		Poland	01-201
82	Katedra i Klinika Chorob Zakaznych	Wroclaw		Poland	51-149
83	Spitalul Clinic Colentina	Bucharest		Romania	20125
84	Institutul Clinic Fundeni	Bucharest		Romania	22328
85	Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"	Bucharest		Romania	30303
86	Spitalul Clinic de Adulti Cluj-Napoca	Cluj-Napoca		Romania	400162
87	Institutul de Gastroenterologie si Hepatologie	Iasi		Romania	700111