Clinical trial NCT00411385: Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Hepatitis C
CHC
HepC
Genotype 1
Hepatitis
HCV
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2006-12-14
Enrollment: 933
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sustained virologic response (SVR)
timeFrame: Week 48
Secondary outcomes:
measure: Rapid virologic response
timeFrame: Week 4
measure: Early virologic response
timeFrame: Week 12
measure: Undetectable HCV RNA
timeFrame: Week 24
measure: Normalization of ALT (a liver enzyme)
timeFrame: Week 48
measure: Quality of life evaluation
timeFrame: Week 48
measure: Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)
timeFrame: Througout the entire treatment period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida-Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Transplant Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Atlanta
country: United States
facility: GI of Atlanta
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Center for Viral Hepatits
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
city: New York
country: United States
facility: New York Hospital - Cornell
state: New York
city: New York
country: United States
facility: Faculty Practice Associates
state: New York
city: New York
country: United States
facility: NY Presbyterian Medical Center - Columbia Univ. Med Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: Alamo Medrical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Capital Federal
country: Argentina
facility: Unidad de Hepatología
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Fundación Cidea
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Hospital Italiano
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Rosario
country: Argentina
facility: Htal Pcial del Centenario
state: Santa Fe
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital Clinical School of Medicine
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Greenslopes
country: Australia
facility: Gallipoli Research Foundation and Greenslopes Private Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Bribane & Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy, Victoria
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Heidelburg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Brussels
country: Belgium
facility: CHU Brugmann ULB - site Victor Horta
city: Brussels
country: Belgium
facility: UCL
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Salvador
country: Brazil
facility: Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
state: BA
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo - UNIFESP
state: SP
city: São Paulo
country: Brazil
facility: Hospital Heliópolis
state: SP
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
state: SP
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba Health Sciences Centre
state: Manitoba
city: London
country: Canada
facility: University of Western Ontario Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Clichy
country: France
facility: Hopital Beaujon
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Lyon Cedex 02
country: France
facility: CHU de Lyon, Hôpital de l'Hôtel Dieu
city: Marseille Cedex 08
country: France
facility: Hopital Saint-Joseph
city: Orleans
country: France
facility: Hopital de La Source
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Pessac cedex
country: France
facility: Hopital Haut-Leveque
city: Toulouse Cedex
country: France
facility: CHU Purpan Clinique Dieulafoy
city: Vandoeuvre
country: France
facility: Hôpital de Brabois
city: Berlin
country: Germany
facility: UH Charite Berlin / Virchow Klinikum
city: Duesseldorf
country: Germany
facility: Universitätsklinik Düsseldorf
city: Düsseldorf
country: Germany
facility: Center for HIV and Hepatogastroenterology
city: Essen
country: Germany
facility: UH Essen
city: Frankfurt / Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universitaet Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universitaet Mainz
city: Marl
country: Germany
facility: Paracelsus Klinik der Stadt Marl
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre and Breach Candy Hospital,
city: Mumbai
country: India
facility: P. D. Hinduja National Hospital and Medical Research Centre
city: New Delhi
country: India
facility: G.B.Pant Hospital
city: New Delhi
country: India
facility: Maulana Azad Medical College and Associated Lok Nayak Hospital
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bundang
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seonnam City
country: Korea, Republic of
facility: Seoul National University Hospital(Bundang)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital(SVR)
city: Seoul
country: Korea, Republic of
facility: Kyunghee University - Medical center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yongdong Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center(Anam)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center(Guro)
city: Suwon
country: Korea, Republic of
facility: Aju University Hospital
city: Alor Setar
country: Malaysia
facility: Hospital Alor Setar
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuala Lumpur
country: Malaysia
facility: HUKM
city: Selangor
country: Malaysia
facility: Hospital Selayang
city: Monterrey N.L.
country: Mexico
facility: Hosp. Universitario. Monterrey
state: CP
city: Mexico
country: Mexico
facility: Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"
state: DF
city: Mexico City
country: Mexico
facility: Clínica Lomas Altas
city: Bialystok
country: Poland
facility: Wojewódzki Szpital Specjalistyczny
city: Czeladz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Kielce
country: Poland
facility: Wojewódzki Szpital Zespolony
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Uniwersytet Medyczny
city: Warszawa
country: Poland
facility: Wojewódzki Szpital Zakaźny
city: Wroclaw
country: Poland
facility: Przychodnia przy Łowieckie
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: CGH
city: Badalona - Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hopital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Carlos III
city: Sevilla
country: Spain
facility: Complejo Hospitalario Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Malmö
country: Sweden
facility: Universitetssjukhuset MAS
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Hualien
country: Taiwan
facility: TCGH-HL
state: R.o.c.
city: Kaohsiung
country: Taiwan
facility: KMUH
state: R.o.c.
city: Kaohsiung
country: Taiwan
facility: KCGMH
state: R.o.c.
city: Taichung
country: Taiwan
facility: VGH-TC
state: R.o.c.
city: Taipei
country: Taiwan
facility: NTUH
state: R.o.c.
city: Taipei
country: Taiwan
facility: TSGH
state: R.o.c.
city: Taoyuan
country: Taiwan
facility: CGMH-LK
state: R.o.c.
city: Changhua
country: Taiwan
facility: CCH
city: Taichung
country: Taiwan
facility: CMUH
city: Tainan
country: Taiwan
facility: NCKUH
city: Tainan
country: Taiwan
facility: CMMC
city: Taipei
country: Taiwan
facility: TCGH-TP
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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-naive patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. doi: 10.1016/j.hepres.2006.04.005. Epub 2006 May 30.
citation: 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. doi: 10.1016/j.jhep.2005.12.011. Epub 2006 Jan 30.
citation: 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
citation: 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
citation: 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.
citation: Nelson DR, Benhamou Y, Chuang WL, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JW, Kryczka W, Lee CM, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-2/3 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3. Gastroenterology. 2010 Oct;139(4):1267-76. doi: 10.1053/j.gastro.2010.06.062. Epub 2010 Jul 1.