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Chronic Hepatitis CPhase 3NCT00411385

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

A Phase 3 study testing albumin interferon alfa-2b, peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by Human Genome Sciences Inc. at 159 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
albumin interferon alfa-2b, peginterferon alfa-2a and Ribavirin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
933 participants
Where
159 sitesin 21 countries
Study dates
Feb 2007to Oct 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

159 sites in 21 countries.

159 sites in 21 countries

United States28 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • GI of Atlanta

    Atlanta, Georgia, 30309

  • Johns Hopkins Center for Viral Hepatits

    Baltimore, Maryland, 21287

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7584

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • University of Colorado

    Denver, Colorado, 80262-0001

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • University of Florida-Gainesville

    Gainesville, Florida, 32610

  • Shands Jacksonville Medical Center

    Jacksonville, Florida, 32209

  • Mayo Clinic Transplant Center

    Jacksonville, Florida, 32216

  • Scripps Clinic

    La Jolla, California, 92037

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604-3200

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Miami

    Miami, Florida, 33136-1051

  • New York Hospital - Cornell

    New York, New York, 10021

  • Faculty Practice Associates

    New York, New York, 10029

  • NY Presbyterian Medical Center - Columbia Univ. Med Center

    New York, New York, 10032

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota, 55446

  • Alamo Medrical Research

    San Antonio, Texas, 78215

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Bronx VA Medical Center

    The Bronx, New York, 10468

Other trials in United States

Australia15 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital

    Fitzroy, Victoria, Victoria, 3065

  • Western Hospital

    Footscray, Victoria, 3011

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Gallipoli Research Foundation and Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Austin Hospital

    Heidelburg, Victoria, 3081

  • Royal Bribane & Women's Hospital

    Herston, Queensland, 4029

  • St George Hospital Clinical School of Medicine

    Kogarah, New South Wales, 2217

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

South Korea12 sites

  • Bundang CHA Hospital

    Bundang, 463-712

  • Kyungpook National University Hospital

    Daegu, 700-721

  • Pusan National University Hospital

    Pusan, 602-739

  • Seoul National University Hospital(Bundang)

    Seonnam City, 463-802

  • Severance Hospital(SVR)

    Seoul, 120-752

  • Kyunghee University - Medical center

    Seoul, 130-702

  • Samsung Medical Center

    Seoul, 135-710

  • Yongdong Severance Hospital

    Seoul, 135-720

  • Korea University Medical Center(Anam)

    Seoul, 136-705

  • Asan Medical Center

    Seoul, 138-736

  • Korea University Medical Center(Guro)

    Seoul, 152-703

  • Aju University Hospital

    Suwon, 443-821

Other trials in South Korea

Taiwan12 sites

  • CCH

    Changhua, 500

  • TCGH-HL

    Hualien City, R.o.c., 970

  • KMUH

    Kaohsiung City, R.o.c., 807

  • KCGMH

    Kaohsiung City, R.o.c., 833

  • VGH-TC

    Taichung, R.o.c., 407

  • CMUH

    Taichung, 404

  • NCKUH

    Tainan, 704

  • CMMC

    Tainan, 710

  • NTUH

    Taipei, R.o.c., 100

  • TSGH

    Taipei, R.o.c., 114

  • TCGH-TP

    Taipei, 231

  • CGMH-LK

    Taoyuan, R.o.c., 333

Other trials in Taiwan

Germany11 sites

  • UH Charite Berlin / Virchow Klinikum

    Berlin, 13353

  • Center for HIV and Hepatogastroenterology

    Düsseldorf, 40237

  • Universitätsklinik Düsseldorf

    Düsseldorf, 40255

  • UH Essen

    Essen, 45122

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, 60590

  • Albert-Ludwigs-Universitaet Freiburg

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30623

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Leipzig

    Leipzig, 4103

  • Johannes Gutenberg-Universitaet Mainz

    Mainz, 55101

  • Paracelsus Klinik der Stadt Marl

    Marl, 45770

Other trials in Germany

Canada10 sites

  • Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4N1

  • University of Alberta

    Edmonton, Alberta, T5H 4B9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2X8

  • University of Western Ontario Hospital

    London, Ontario, N6A 5A5

  • McGill University

    Montreal, Quebec, H3A 1A1

  • Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3P1

  • University of Manitoba Health Sciences Centre

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

France10 sites

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Lyon, Hôpital de l'Hôtel Dieu

    Lyon, 69288

  • Hopital Saint-Joseph

    Marseille, 13285

  • Hopital de La Source

    Orléans, 45100

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hopital Pitie-Salpetriere

    Paris, 75013

  • Hopital Haut-Leveque

    Pessac, 33600

  • CHU Purpan Clinique Dieulafoy

    Toulouse, 31059

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain8 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona - Barcelona, 8916

  • Hopital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital Clinic i Provincial

    Barcelona, 8036

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Carlos III

    Madrid, 28029

  • Complejo Hospitalario Nuestra Señora de Valme

    Seville, 41014

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Poland7 sites

  • Wojewódzki Szpital Specjalistyczny

    Bialystok, 15-540

  • Niepubliczny Zaklad Opieki Zdrowotnej

    Czeladź, 41-250

  • Wojewódzki Szpital Zespolony

    Kielce, 25-317

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-531

  • Uniwersytet Medyczny

    Lodz, 91-347

  • Wojewódzki Szpital Zakaźny

    Warsaw, 01-201

  • Przychodnia przy Łowieckie

    Wroclaw, 50-220

Other trials in Poland

Israel6 sites

  • Bnei-Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 31096

  • Hadassah Medical Organization

    Jerusalem, 91120

  • Holy Family Hospital

    Nazareth, 16100

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Argentina5 sites

  • Unidad de Hepatología

    Capital Federal, Buenos Aires, C1093AAS

  • Fundación Cidea

    Capital Federal, Buenos Aires, C1121ABE

  • Hospital Italiano

    Capital Federal, Buenos Aires, C1181ACH

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629AHJ

  • Htal Pcial del Centenario

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Belgium5 sites

  • CHU Brugmann ULB - site Victor Horta

    Brussels, 1020

  • UCL

    Brussels, 1200

  • University Hospital Antwerp

    Edegem, 2650

  • Ghent University Hospital

    Ghent, 9000

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

Brazil5 sites

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    Ribeirão Preto, São Paulo, 14049-900

  • Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia

    Salvador, Estado de Bahia, 40110-170

  • Universidade Federal de São Paulo - UNIFESP

    São Paulo, São Paulo, 04023-900

  • Hospital Heliópolis

    São Paulo, São Paulo, 04230-000

  • Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

India5 sites

  • Dayanand Medical College and Hospital

    Ludhiana, 141001

  • Jaslok Hospital and Research Centre and Breach Candy Hospital,

    Mumbai, 400 0026

  • P. D. Hinduja National Hospital and Medical Research Centre

    Mumbai, 400 016

  • G.B.Pant Hospital

    New Delhi, 110 002

  • Maulana Azad Medical College and Associated Lok Nayak Hospital

    New Delhi, 110 002

Other trials in India

Malaysia5 sites

  • Hospital Alor Setar

    Alor Star, 5150

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 50603

  • HUKM

    Kuala Lumpur, 56000

  • Hospital Selayang

    Kuala Selangor, 68100

Other trials in Malaysia

Singapore4 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

  • CGH

    Singapore, 529889

Other trials in Singapore

Thailand4 sites

  • Chulalongkorn Hospital

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

Mexico3 sites

  • Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"

    Mexico City, Mexico City, 14000

  • Clínica Lomas Altas

    Mexico City, 11950

  • Hosp. Universitario. Monterrey

    Monterrey N.L., CP, 64460

Other trials in Mexico

Sweden2 sites

  • Universitetssjukhuset MAS

    Malmö, 205 02

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

Other trials in Sweden

Puerto Rico1 site

  • Fundacion de Investigacion de Diego

    Santurce, 909

Other trials in Puerto Rico

United Kingdom1 site

  • Barts and the London NHS Trust

    London, E1 2AT

Other trials in United Kingdom

About this study

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.

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.

Being tested
albumin interferon alfa-2b, peginterferon alfa-2a, Ribavirin
Keywords
Chronic Hepatitis C, Hepatitis C, CHC, HepC, Genotype 1, Hepatitis, HCV
Medical subject headings
Hepatitis C, Chronic, Hepatitis C, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • albumin interferon alfa-2bDrug

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

  • peginterferon alfa-2aDrug

    180 micrograms Pegasys given subcutaneaously once a week for 24 weeks

  • RibavirinDrug

    800mg/day for 24 weeks

Study groups in NCT00411385
Study groupRoleWhat they receive
1Experimental900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Receives: Drug: albumin interferon alfa-2b; Drug: Ribavirin
2Experimental1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Receives: Drug: albumin interferon alfa-2b; Drug: Ribavirin
3Active comparator180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained virologic response (SVR)

    Measured: Week 48

Secondary outcomes (6)

  1. Rapid virologic response

    Measured: Week 4

  2. Early virologic response

    Measured: Week 12

  3. Undetectable HCV RNA

    Measured: Week 24

  4. Normalization of ALT (a liver enzyme)

    Measured: Week 48

  5. Quality of life evaluation

    Measured: Week 48

  6. Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)

    Measured: Througout the entire treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2006 (estimated)
  2. Study startFeb 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
933 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00411385
Sponsor's protocol ID
HGS1008-C1067
Other IDs
ACHIEVE-2/3
Status last verified
Aug 2013
First submitted
13 Dec 2006
Last updated
8 Aug 2013
Results posted
No

Publications

  • 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.

    PubMed 16731032

  • 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.

    PubMed 16487617

  • 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

  • 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.

    PubMed 16518958

  • 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.

    PubMed 20600017

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing albumin interferon alfa-2b, peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by Human Genome Sciences Inc. at 159 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Australia, South Korea, Taiwan, Germany and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained virologic response (SVR) (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00411385, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2013.

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