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

• Sponsor: Human Genome Sciences Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00402428
• Collaborator: Novartis (Industry)
• Enrollment: 1,331
• Locations: 165
• Arms: 3
• Duration (Months): 26.1
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.3

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 1 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: 1331 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day	Drug: peginterferon alfa-2a; 180 mcg once a week for 48 weeks; Drug: Ribavirin; 1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg)
Experimental: 2 900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day	Drug: albumin interferon alfa-2b; 900 mcg or 1200mcg every two week for 48 weeks; Drug: Ribavirin; 1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg)
Experimental: 3 1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day	Drug: albumin interferon alfa-2b; 900 mcg or 1200mcg every two week for 48 weeks; Drug: Ribavirin; 1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg)

Outcome Measures

Primary Outcome Measures

1. Sustained virologic response (SVR) [Week 72]

Secondary Outcome Measures

1. Rapid virologic response [Week 4]

2. Early virologic response [Week 12]

3. Undetectable HCV RNA [Week 24 and Week 48]

4. Normalization of ALT (a liver enzyme) [Week 48]

5. Quality of life evaluation [throughout the entire study]

6. Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing) [Throughout the entire study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 1.

• 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	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Mayo Clinic Hospital	Phoenix	Arizona	United States	85054
3	UCSF Fresno	Fresno	California	United States	93702
4	Scripps Clinic	La Jolla	California	United States	92037
5	USC Keck School of Medicine	Los Angeles	California	United States	90033
6	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
7	UCLA / West LA VAMC	Los Angeles	California	United States	90073
8	Huntington Medical Research Institutes	Pasadena	California	United States	91105
9	University California-San Diego	San Diego	California	United States	92103-8707
10	San Diego Digestive Diseases Consultants, Inc	San Diego	California	United States	92123
11	VA San Diego Healthcare	San Diego	California	United States	92161
12	California Pacific Medical Center	San Francisco	California	United States	94115
13	University of California at San Francisco	San Francisco	California	United States	94143-0538
14	University of Colorado	Denver	Colorado	United States	80262-0001
15	University of Colorado Health Sciences Ctr	Englewood	Colorado	United States	80113
16	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307
17	University of Florida - Gainesville	Gainesville	Florida	United States	32610
18	Shands Jacksonville Medical Center	Jacksonville	Florida	United States	32209
19	Mayo Clinic Transplant Center	Jacksonville	Florida	United States	32216
20	Va Health Care System	Miami	Florida	United States	33125
21	University of Miami	Miami	Florida	United States	33136-1051
22	Venture Research Institute	N. Miami Beach	Florida	United States	33162
23	University Hepatitis Center	Sarasota	Florida	United States	34243
24	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States	30308
25	GI of Atlanta	Atlanta	Georgia	United States	30309
26	Northwest Georgia Gastroenterology Associates	Marietta	Georgia	United States	30060
27	Alan D Tice, MD, LLC	Honolulu	Hawaii	United States	96813
28	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
29	Indiania University School of Medicine	Indianapolis	Indiana	United States	46202
30	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
31	University of Louisville	Louisville	Kentucky	United States	40202
32	Tulane University Health Sciences Center	New Orleans	Louisiana	United States	70112
33	University of Maryland	Baltimore	Maryland	United States	21021-1544
34	Johns Hopkins Center for Viral Hepatits	Baltimore	Maryland	United States	21287
35	Maryland Digestive Disease Center	Laurel	Maryland	United States	20707
36	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
37	Henry Ford Health System	Detroit	Michigan	United States	48202
38	Mayo Clinic	Rochester	Minnesota	United States	55905
39	Digestive Health Specialist	Tupelo	Mississippi	United States	38801
40	St. Louis University	St Louis	Missouri	United States	63104
41	University of New Mexico	Albuquerque	New Mexico	United States	87131-0001
42	North Shore University Hospital	Manhasset	New York	United States	11030
43	New York Hospital - Cornell	New York	New York	United States	10021
44	Faculty Practice Associates	New York	New York	United States	10029
45	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7584
46	Duke Medical Center	Durham	North Carolina	United States	27705
47	University of Cincinnati	Cincinnati	Ohio	United States	95267-0595
48	Hospital of University of PA	Philadelphia	Pennsylvania	United States	19104
49	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
50	Memphis Gastroenterology Group	Germantown	Tennessee	United States	38138
51	Nashville Gastroenterology	Nashville	Tennessee	United States	37205
52	Nashville Gastrointestinal Specialists	Nashville	Tennessee	United States	37211
53	Liver Institute at Methodist Dallas	Dallas	Texas	United States	75208
54	Baylor University Medical Center	Dallas	Texas	United States	75246
55	UT Southwesten Medical Center	Dallas	Texas	United States	75390-8887
56	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
57	GI & Liver Assoicates	Granbury	Texas	United States	76048
58	Liver Specialist of Texas	Houston	Texas	United States	77030-2312
59	Alamo Medical Research	San Antonio	Texas	United States	78215
60	INOVA Fairfax Hospital	Annandale	Virginia	United States	22003
61	Metropolitan Research	Fairfax	Virginia	United States	22031
62	Virginia Commonwealth University Medical Ctr	Richmond	Virginia	United States	23298
63	University of Washington	Seattle	Washington	United States	98195-6174
64	University of Wisconsin-Madison	Madison	Wisconsin	United States	53792-5124
65	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
66	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
67	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
68	St George Hospital Clinical School of Medicine University of New South Wales	Kogarah	New South Wales	Australia	2217
69	John Hunter Hospital	New Lambton	New South Wales	Australia	2305
70	Westmead Hospital	Westmead	New South Wales	Australia	2145
71	Greenslopes Private Hospital	Greenslopes	Queensland	Australia	4120
72	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
73	Monash Medical Centre	Clayton	Victoria	Australia	3168
74	St Vincent's Hospital	Fitzroy, Victoria	Victoria	Australia	3065
75	Western Hospital	Footscray	Victoria	Australia	3011
76	Austin Hospital	Heidelburg	Victoria	Australia	3081
77	The Alfred Hospital	Melbourne	Victoria	Australia	3004
78	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
79	Fremantle Hospital	Fremantle	Western Australia	Australia	6160
80	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
81	Royal Perth Hospital	Perth		Australia	6000
82	Medizinische Universitätsklinik Graz	Graz		Austria	8036
83	Univ.-Klinik fuer Innere Medizin	Innsbruck		Austria	6020
84	Medical University of Vienna	Wien		Austria	1090
85	Heritage Medical Research Clinic	Calgary	Alberta	Canada	T2N 4N1
86	University of Alberta	Edmonton	Alberta	Canada	T5H 4B9
87	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2X8
88	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 3P1
89	University of Manitoba Health Sciences Centre	Winnipeg	Manitoba	Canada	R3E 3P4
90	Dalhousie University	Halifax	Nova Scotia	Canada	B3H 2Y9
91	University of Western Ontario Hospital	London	Ontario	Canada	N6A 5A5
92	Ottawa Hospital - General Campus	Ottawa	Ontario	Canada	K1H 8L6
93	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2N2
94	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
95	McGill University	Montreal	Quebec	Canada	H3A 1A1
96	Klinika infekcních chorob	Brno		Czech Republic	62500
97	Klinika Infekcních nemocí	Hradec Kralove		Czech Republic	50005
98	Nemocnice s poliklinikou Melník	Melnik		Czech Republic	27601
99	Slezská nemocnice	Opava		Czech Republic	74601
100	Vseobecna fakultní nemocnice	Praha 2		Czech Republic	12808
101	Nuselská poliklinika	Praha 4		Czech Republic	14000
102	Ambulance pro interni a infekcni nemoci	Usti nad Labem		Czech Republic	40001
103	Hopital Beaujon	Clichy		France	92110
104	Hopital Henri Mondor	Creteil		France	94010
105	CHU de Lyon, Hôpital de l'Hôtel Dieu	Lyon Cedex 02		France	69288
106	Hopital Saint-Joseph	Marseille Cedex 08		France	13285
107	Hopital de La Source	Orleans		France	45100
108	Hôpital Saint-Antoine	Paris		France	75012
109	Hopital Pitie-Salpetriere	Paris		France	75013
110	Hopital Haut-Leveque	Pessac cedex		France	33600
111	CHU Purpan Clinique Dieulafoy	Toulouse Cedex		France	31059
112	Hôpital de Brabois	Vandoeuvre		France	54511
113	UH Charite Berlin / Virchow Klinikum	Berlin		Germany	13353
114	Universitätsklinik Düsseldorf	Duesseldorf		Germany	40255
115	Center for HIV and Hepatogastroenterology	Düsseldorf		Germany	40237
116	UH Essen	Essen		Germany	45122
117	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt / Main		Germany	60590
118	Albert-Ludwigs-Universitaet Freiburg	Freiburg		Germany	79106
119	Medizinische Hochschule Hannover (MHH)	Hannover		Germany	30623
120	Universitätsklinikum Heidelberg	Heidelberg		Germany	69120
121	Universitätsklinikum Leipzig	Leipzig		Germany	4103
122	Johannes Gutenberg-Universitaet Mainz	Mainz		Germany	55101
123	Paracelsus Klinik der Stadt Marl	Marl		Germany	45770
124	Dayanand Medical College and Hospital	Ludhiana		India	141001
125	Jaslok Hospital and Research Centre and Breach Candy Hospital,	Mumbai		India	400 0026
126	G.B.Pant Hospital	New Delhi		India	110 002
127	Bnei-Zion Medical Center	Haifa		Israel	31048
128	Rambam Health Care Campus	Haifa		Israel	31096
129	Hadassah Medical Organization	Jerusalem		Israel	91120
130	Holy Family Hospital	Nazareth		Israel	16100
131	Rabin Medical Center Beilinson Campus	Petach Tikva		Israel	49100
132	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239
133	Policlinico S.Orsola Malpighi	Bologna		Italy	40138
134	IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano	Milano		Italy	20122
135	Seconda Università di Napoli c/o Secondo Policlinico	Napoli		Italy	80131
136	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo		Italy	90127
137	I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia	Pavia		Italy	27100
138	Casa Sollievo della Sofferenza IRCCS	San Giovanni Rotondo (FG)		Italy	71013
139	Azienda Ospedaliera S. Giovanni Battista Molinette	Torino		Italy	10126
140	Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego	Białystok		Poland	15-540
141	Szpital Specjalistyczny	Chorzow		Poland	41-500
142	Wojewódzki Szpital Zespolony	Kielce		Poland	25-317
143	Szpital Uniwersytecki w Krakowie	Kraków		Poland	31-531
144	Akademia Medyczna	Warszawa		Poland	01-201
145	Wojewódzki Szpital Zaka?ny	Warszawa		Poland	01-201
146	Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego	Wrocław		Poland	51-149
147	Uniwersytet Medyczny	Łódź		Poland	91-347
148	Fundacion de Investigacion de Diego	Santurce		Puerto Rico	909
149	Spitalul Clinic Colentina	Bucharest		Romania	20125
150	Institutul Clinic Fundeni	Bucharest		Romania	22328
151	Spitalul Clinic Dr.Victor Babes	Bucharest		Romania	30303
152	Spitalul Clinic de Adulti Cluj-Napoca	Cluj-Napoca		Romania	400162
153	Institutul de Gastroenterologie si Hepatologie	Lasi		Romania	700111
154	Hospital Universitari Germans Trias i Pujol	Badalona - Barcelona		Spain	8916
155	Hopital Universitari Vall d'Hebron	Barcelona		Spain	8035
156	Hospital Clinic i Provincial	Barcelona		Spain	8036
157	Hospital Universitario La Princesa	Madrid		Spain	28006
158	Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007
159	Hospital Carlos III	Madrid		Spain	28029
160	Consorcio Hospital General Universitario de Valencia	Valencia		Spain	46014
161	Queen Elizabeth Medical Centre	Birmingham		United Kingdom	B15 2TH
162	Royal London Hospital	London		United Kingdom	E1 2AT
163	Imperial College London St Mary's Hospital Campus	London		United Kingdom	W2 1PG
164	Nottingham University Hospitals NHS Trust Queens Medical Centre Campus	Nottingham		United Kingdom	NG7 2UH
165	Derriford Hospital	Plymouth		United Kingdom	PL6 8DH

Sponsors and Collaborators

• Human Genome Sciences Inc.
• Novartis

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. Epub 2006 Jan 30.
• Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naïve patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. Epub 2006 May 30.
• Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45.
• S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006
• Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006

• Responsible Party: Human Genome Sciences Inc.
• ClinicalTrials.gov Identifier: NCT00402428
• Other Study ID Numbers: HGS1008-C1060; ACHIEVE-1
• First Posted: Nov 22, 2006
• Last Update Posted: Aug 8, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Human Genome Sciences Inc.: Chronic Hepatitis C; Hepatitis C; CHC; HepC; Genotype 1; Hepatitis; HCV
• Additional relevant MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a

Study Results

No Results Posted as of Aug 8, 2013