Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

Sponsor

Human Genome Sciences Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00411385

Collaborator

Novartis (Industry)

933

Enrollment

159

Locations

Arms

Duration (Months)

5.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: albumin interferon alfa-2b Drug: peginterferon alfa-2a Drug: Ribavirin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

933 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day	Drug: albumin interferon alfa-2b 900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks Drug: Ribavirin 800mg/day for 24 weeks
Experimental: 2 1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day	Drug: albumin interferon alfa-2b 900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks Drug: Ribavirin 800mg/day for 24 weeks
Active Comparator: 3 180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day	Drug: peginterferon alfa-2a 180 micrograms Pegasys given subcutaneaously once a week for 24 weeks Drug: Ribavirin 800mg/day for 24 weeks

Arm

Intervention/Treatment

Experimental: 1

900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day

Drug: albumin interferon alfa-2b

900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks

Drug: Ribavirin

800mg/day for 24 weeks

Experimental: 2

1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day

Drug: albumin interferon alfa-2b

900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks

Drug: Ribavirin

800mg/day for 24 weeks

Active Comparator: 3

180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day

Drug: peginterferon alfa-2a

180 micrograms Pegasys given subcutaneaously once a week for 24 weeks

Drug: Ribavirin

800mg/day for 24 weeks

Outcome Measures

Primary Outcome Measures

Sustained virologic response (SVR) [Week 48]

Secondary Outcome Measures

Rapid virologic response [Week 4]
Early virologic response [Week 12]
Undetectable HCV RNA [Week 24]
Normalization of ALT (a liver enzyme) [Week 48]
Quality of life evaluation [Week 48]
Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results) [Througout the entire treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Diagnosis of chronic hepatitis C.
Liver biopsy performed within 2 years of Day 0 or during screening.
Infected with hepatitis C virus genotype 2/3.
Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
Have compensated liver disease.

Key Exclusion Criteria:

Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
Active seizure disorder within the last 2 years.
Organ transplant other than cornea and hair transplant.
Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
Received any experimental agent within 28 days prior to Day 0.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Hospital	Phoenix	Arizona	United States	85054
2	Scripps Clinic	La Jolla	California	United States	92037
3	California Pacific Medical Center	San Francisco	California	United States	94115
4	University of Colorado	Denver	Colorado	United States	80262-0001
5	University of Florida-Gainesville	Gainesville	Florida	United States	32610
6	Shands Jacksonville Medical Center	Jacksonville	Florida	United States	32209
7	Mayo Clinic Transplant Center	Jacksonville	Florida	United States	32216
8	University of Miami	Miami	Florida	United States	33136-1051
9	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States	30308
10	GI of Atlanta	Atlanta	Georgia	United States	30309
11	University of Chicago Hospital	Chicago	Illinois	United States	60637
12	Johns Hopkins Center for Viral Hepatits	Baltimore	Maryland	United States	21287
13	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
14	Minnesota Gastroenterology, P.A.	Plymouth	Minnesota	United States	55446
15	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
16	University of New Mexico	Albuquerque	New Mexico	United States	87131-0001
17	Bronx VA Medical Center	Bronx	New York	United States	10468
18	New York Hospital - Cornell	New York	New York	United States	10021
19	Faculty Practice Associates	New York	New York	United States	10029
20	NY Presbyterian Medical Center - Columbia Univ. Med Center	New York	New York	United States	10032
21	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7584
22	Regional Gastroenterology Associates of Lancaster, Ltd.	Lancaster	Pennsylvania	United States	17604-3200
23	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
24	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
25	Baylor University Medical Center	Dallas	Texas	United States	75246
26	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
27	Alamo Medrical Research	San Antonio	Texas	United States	78215
28	Metropolitan Research	Fairfax	Virginia	United States	22031
29	Unidad de Hepatología	Capital Federal	Buenos Aires	Argentina	C1093AAS
30	Fundación Cidea	Capital Federal	Buenos Aires	Argentina	C1121ABE
31	Hospital Italiano	Capital Federal	Buenos Aires	Argentina	C1181ACH
32	Hospital Universitario Austral	Pilar	Buenos Aires	Argentina	B1629AHJ
33	Htal Pcial del Centenario	Rosario	Santa Fe	Argentina	2000
34	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
35	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
36	St George Hospital Clinical School of Medicine	Kogarah	New South Wales	Australia	2217
37	John Hunter Hospital	New Lambton	New South Wales	Australia	2305
38	Westmead Hospital	Westmead	New South Wales	Australia	2145
39	Gallipoli Research Foundation and Greenslopes Private Hospital	Greenslopes	Queensland	Australia	4120
40	Royal Bribane & Women's Hospital	Herston	Queensland	Australia	4029
41	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
42	Monash Medical Centre	Clayton	Victoria	Australia	3168
43	St Vincent's Hospital	Fitzroy, Victoria	Victoria	Australia	3065
44	Western Hospital	Footscray	Victoria	Australia	3011
45	Austin Hospital	Heidelburg	Victoria	Australia	3081
46	The Alfred Hospital	Melbourne	Victoria	Australia	3004
47	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
48	Fremantle Hospital	Fremantle	Western Australia	Australia	6160
49	CHU Brugmann ULB - site Victor Horta	Brussels		Belgium	1020
50	UCL	Brussels		Belgium	1200
51	University Hospital Antwerp	Edegem		Belgium	2650
52	Ghent University Hospital	Gent		Belgium	9000
53	CHU Sart Tilman	Liège		Belgium	4000
54	Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia	Salvador	BA	Brazil	40110-170
55	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Ribeirão Preto	SP	Brazil	14049-900
56	Universidade Federal de São Paulo - UNIFESP	São Paulo	SP	Brazil	04023-900
57	Hospital Heliópolis	São Paulo	SP	Brazil	04230-000
58	Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo	SP	Brazil	05403-000
59	Heritage Medical Research Clinic	Calgary	Alberta	Canada	T2N 4N1
60	University of Alberta	Edmonton	Alberta	Canada	T5H 4B9
61	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2X8
62	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 3P1
63	University of Manitoba Health Sciences Centre	Winnipeg	Manitoba	Canada	R3E 3P4
64	University of Western Ontario Hospital	London	Ontario	Canada	N6A 5A5
65	Ottawa Hospital - General Campus	Ottawa	Ontario	Canada	K1H 8L6
66	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2N2
67	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
68	McGill University	Montreal	Quebec	Canada	H3A 1A1
69	Hopital Beaujon	Clichy		France	92110
70	Hopital Henri Mondor	Creteil		France	94010
71	CHU de Lyon, Hôpital de l'Hôtel Dieu	Lyon Cedex 02		France	69288
72	Hopital Saint-Joseph	Marseille Cedex 08		France	13285
73	Hopital de La Source	Orleans		France	45100
74	Hôpital Saint-Antoine	Paris		France	75012
75	Hopital Pitie-Salpetriere	Paris		France	75013
76	Hopital Haut-Leveque	Pessac cedex		France	33600
77	CHU Purpan Clinique Dieulafoy	Toulouse Cedex		France	31059
78	Hôpital de Brabois	Vandoeuvre		France	54511
79	UH Charite Berlin / Virchow Klinikum	Berlin		Germany	13353
80	Universitätsklinik Düsseldorf	Duesseldorf		Germany	40255
81	Center for HIV and Hepatogastroenterology	Düsseldorf		Germany	40237
82	UH Essen	Essen		Germany	45122
83	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt / Main		Germany	60590
84	Albert-Ludwigs-Universitaet Freiburg	Freiburg		Germany	79106
85	Medizinische Hochschule Hannover (MHH)	Hannover		Germany	30623
86	Universitätsklinikum Heidelberg	Heidelberg		Germany	69120
87	Universitätsklinikum Leipzig	Leipzig		Germany	4103
88	Johannes Gutenberg-Universitaet Mainz	Mainz		Germany	55101
89	Paracelsus Klinik der Stadt Marl	Marl		Germany	45770
90	Dayanand Medical College and Hospital	Ludhiana		India	141001
91	Jaslok Hospital and Research Centre and Breach Candy Hospital,	Mumbai		India	400 0026
92	P. D. Hinduja National Hospital and Medical Research Centre	Mumbai		India	400 016
93	G.B.Pant Hospital	New Delhi		India	110 002
94	Maulana Azad Medical College and Associated Lok Nayak Hospital	New Delhi		India	110 002
95	Bnei-Zion Medical Center	Haifa		Israel	31048
96	Rambam Health Care Campus	Haifa		Israel	31096
97	Hadassah Medical Organization	Jerusalem		Israel	91120
98	Holy Family Hospital	Nazareth		Israel	16100
99	Rabin Medical Center Beilinson Campus	Petach Tikva		Israel	49100
100	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239
101	Bundang CHA Hospital	Bundang		Korea, Republic of	463-712
102	Kyungpook National University Hospital	Daegu		Korea, Republic of	700-721
103	Pusan National University Hospital	Pusan		Korea, Republic of	602-739
104	Seoul National University Hospital(Bundang)	Seonnam City		Korea, Republic of	463-802
105	Severance Hospital(SVR)	Seoul		Korea, Republic of	120-752
106	Kyunghee University - Medical center	Seoul		Korea, Republic of	130-702
107	Samsung Medical Center	Seoul		Korea, Republic of	135-710
108	Yongdong Severance Hospital	Seoul		Korea, Republic of	135-720
109	Korea University Medical Center(Anam)	Seoul		Korea, Republic of	136-705
110	Asan Medical Center	Seoul		Korea, Republic of	138-736
111	Korea University Medical Center(Guro)	Seoul		Korea, Republic of	152-703
112	Aju University Hospital	Suwon		Korea, Republic of	443-821
113	Hospital Alor Setar	Alor Setar		Malaysia	5150
114	Hospital Kuala Lumpur	Kuala Lumpur		Malaysia	50586
115	University Malaya Medical Centre	Kuala Lumpur		Malaysia	50603
116	HUKM	Kuala Lumpur		Malaysia	56000
117	Hospital Selayang	Selangor		Malaysia	68100
118	Hosp. Universitario. Monterrey	Monterrey N.L.	CP	Mexico	64460
119	Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"	Mexico	DF	Mexico	14000
120	Clínica Lomas Altas	Mexico City		Mexico	11950
121	Wojewódzki Szpital Specjalistyczny	Bialystok		Poland	15-540
122	Niepubliczny Zaklad Opieki Zdrowotnej	Czeladz		Poland	41-250
123	Wojewódzki Szpital Zespolony	Kielce		Poland	25-317
124	Szpital Uniwersytecki w Krakowie	Krakow		Poland	31-531
125	Uniwersytet Medyczny	Lodz		Poland	91-347
126	Wojewódzki Szpital Zakaźny	Warszawa		Poland	01-201
127	Przychodnia przy Łowieckie	Wroclaw		Poland	50-220
128	Fundacion de Investigacion de Diego	Santurce		Puerto Rico	909
129	National University Hospital	Singapore		Singapore	119074
130	Singapore General Hospital	Singapore		Singapore	169608
131	Tan Tock Seng Hospital	Singapore		Singapore	308433
132	CGH	Singapore		Singapore	529889
133	Hospital Universitari Germans Trias i Pujol	Badalona - Barcelona		Spain	8916
134	Hopital Universitari Vall d'Hebron	Barcelona		Spain	8035
135	Hospital Clinic i Provincial	Barcelona		Spain	8036
136	Hospital Universitario La Princesa	Madrid		Spain	28006
137	Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007
138	Hospital Carlos III	Madrid		Spain	28029
139	Complejo Hospitalario Nuestra Señora de Valme	Sevilla		Spain	41014
140	Consorcio Hospital General Universitario de Valencia	Valencia		Spain	46014
141	Universitetssjukhuset MAS	Malmö		Sweden	205 02
142	Karolinska Universitetssjukhuset	Stockholm		Sweden	171 76
143	TCGH-HL	Hualien	R.o.c.	Taiwan	970
144	KMUH	Kaohsiung	R.o.c.	Taiwan	807
145	KCGMH	Kaohsiung	R.o.c.	Taiwan	833
146	VGH-TC	Taichung	R.o.c.	Taiwan	407
147	NTUH	Taipei	R.o.c.	Taiwan	100
148	TSGH	Taipei	R.o.c.	Taiwan	114
149	CGMH-LK	Taoyuan	R.o.c.	Taiwan	333
150	CCH	Changhua		Taiwan	500
151	CMUH	Taichung		Taiwan	404
152	NCKUH	Tainan		Taiwan	704
153	CMMC	Tainan		Taiwan	710
154	TCGH-TP	Taipei		Taiwan	231
155	Chulalongkorn Hospital	Bangkok		Thailand	10330
156	Ramathibodi Hospital	Bangkok		Thailand	10400
157	Siriraj Hospital	Bangkok		Thailand	10700
158	Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University	Chiang Mai		Thailand	50200
159	Barts and the London NHS Trust	London		United Kingdom	E1 2AT