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Chronic Hepatitis CPhase 3NCT00402428

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

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 165 sites in 15 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 1 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,331 participants
Where
165 sitesin 15 countries
Study dates
Dec 2006to Feb 2009
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 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.

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

165 sites in 15 countries.

165 sites in 15 countries

United States65 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • INOVA Fairfax Hospital

    Annandale, Virginia, 22003

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • GI of Atlanta

    Atlanta, Georgia, 30309

  • University of Maryland

    Baltimore, Maryland, 21021-1544

  • Johns Hopkins Center for Viral Hepatits

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7584

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 95267-0595

  • Liver Institute at Methodist Dallas

    Dallas, Texas, 75208

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwesten Medical Center

    Dallas, Texas, 75390-8887

  • University of Colorado

    Denver, Colorado, 80262-0001

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke Medical Center

    Durham, North Carolina, 27705

  • University of Colorado Health Sciences Ctr

    Englewood, Colorado, 80113

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • UCSF Fresno

    Fresno, California, 93702

  • University of Florida - Gainesville

    Gainesville, Florida, 32610

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • GI & Liver Assoicates

    Granbury, Texas, 76048

  • Alan D Tice, MD, LLC

    Honolulu, Hawaii, 96813

  • Liver Specialist of Texas

    Houston, Texas, 77030-2312

  • Indiania University School of Medicine

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Shands Jacksonville Medical Center

    Jacksonville, Florida, 32209

  • Mayo Clinic Transplant Center

    Jacksonville, Florida, 32216

  • Scripps Clinic

    La Jolla, California, 92037

  • Maryland Digestive Disease Center

    Laurel, Maryland, 20707

  • USC Keck School of Medicine

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA / West LA VAMC

    Los Angeles, California, 90073

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792-5124

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Northwest Georgia Gastroenterology Associates

    Marietta, Georgia, 30060

  • Va Health Care System

    Miami, Florida, 33125

  • University of Miami

    Miami, Florida, 33136-1051

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Nashville Gastroenterology

    Nashville, Tennessee, 37205

  • Nashville Gastrointestinal Specialists

    Nashville, Tennessee, 37211

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • New York Hospital - Cornell

    New York, New York, 10021

  • Faculty Practice Associates

    New York, New York, 10029

  • Venture Research Institute

    North Miami Beach, Florida, 33162

  • Huntington Medical Research Institutes

    Pasadena, California, 91105

  • Hospital of University of PA

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Virginia Commonwealth University Medical Ctr

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • University California-San Diego

    San Diego, California, 92103-8707

  • San Diego Digestive Diseases Consultants, Inc

    San Diego, California, 92123

  • VA San Diego Healthcare

    San Diego, California, 92161

  • California Pacific Medical Center

    San Francisco, California, 94115

  • University of California at San Francisco

    San Francisco, California, 94143-0538

  • University Hepatitis Center

    Sarasota, Florida, 34243

  • University of Washington

    Seattle, Washington, 98195-6174

  • St. Louis University

    St Louis, Missouri, 63104

  • Digestive Health Specialist

    Tupelo, Mississippi, 38801

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307

Other trials in United States

Australia16 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

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Austin Hospital

    Heidelburg, Victoria, 3081

  • St George Hospital Clinical School of Medicine University of New South Wales

    Kogarah, New South Wales, 2217

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, 6000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada11 sites

  • Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4N1

  • University of Alberta

    Edmonton, Alberta, T5H 4B9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2X8

  • Dalhousie University

    Halifax, Nova Scotia, B3H 2Y9

  • 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

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

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

Poland8 sites

  • Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego

    Bialystok, 15-540

  • Szpital Specjalistyczny

    Chorzów, 41-500

  • Wojewódzki Szpital Zespolony

    Kielce, 25-317

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-531

  • Uniwersytet Medyczny

    Lodz, 91-347

  • Akademia Medyczna

    Warsaw, 01-201

  • Wojewódzki Szpital Zaka?ny

    Warsaw, 01-201

  • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

    Wroclaw, 51-149

Other trials in Poland

Czechia7 sites

  • Klinika infekcních chorob

    Brno, 62500

  • Klinika Infekcních nemocí

    Hradec Králové, 50005

  • Nemocnice s poliklinikou Melník

    Mělník, 27601

  • Slezská nemocnice

    Opava, 74601

  • Vseobecna fakultní nemocnice

    Prague, 12808

  • Nuselská poliklinika

    Prague, 14000

  • Ambulance pro interni a infekcni nemoci

    Ústí nad Labem, 40001

Other trials in Czechia

Italy7 sites

  • Policlinico S.Orsola Malpighi

    Bologna, 40138

  • IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano

    Milan, 20122

  • Seconda Università di Napoli c/o Secondo Policlinico

    Naples, 80131

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia

    Pavia, 27100

  • Casa Sollievo della Sofferenza IRCCS

    San Giovanni Rotondo (FG), 71013

  • Azienda Ospedaliera S. Giovanni Battista Molinette

    Torino, 10126

Other trials in Italy

Spain7 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

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

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

Romania5 sites

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Institutul Clinic Fundeni

    Bucharest, 22328

  • Spitalul Clinic Dr.Victor Babes

    Bucharest, 30303

  • Spitalul Clinic de Adulti Cluj-Napoca

    Cluj-Napoca, 400162

  • Institutul de Gastroenterologie si Hepatologie

    Lasi, 700111

Other trials in Romania

United Kingdom5 sites

  • Queen Elizabeth Medical Centre

    Birmingham, B15 2TH

  • Royal London Hospital

    London, E1 2AT

  • Imperial College London St Mary's Hospital Campus

    London, W2 1PG

  • Nottingham University Hospitals NHS Trust Queens Medical Centre Campus

    Nottingham, NG7 2UH

  • Derriford Hospital

    Plymouth, PL6 8DH

Other trials in United Kingdom

Austria3 sites

  • Medizinische Universitätsklinik Graz

    Graz, 8036

  • Univ.-Klinik fuer Innere Medizin

    Innsbruck, 6020

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

India3 sites

  • Dayanand Medical College and Hospital

    Ludhiana, 141001

  • Jaslok Hospital and Research Centre and Breach Candy Hospital,

    Mumbai, 400 0026

  • G.B.Pant Hospital

    New Delhi, 110 002

Other trials in India

Puerto Rico1 site

  • Fundacion de Investigacion de Diego

    Santurce, 909

Other trials in Puerto Rico

About this study

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

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.

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 mcg or 1200mcg every two week for 48 weeks

  • peginterferon alfa-2aDrug

    180 mcg once a week for 48 weeks

  • RibavirinDrug

    1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects

    =,> 75kg)

Study groups in NCT00402428
Study groupRoleWhat they receive
1Active comparator180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin
2Experimental900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Receives: Drug: albumin interferon alfa-2b; Drug: Ribavirin
3Experimental1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
Receives: Drug: albumin interferon alfa-2b; 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 72

Secondary outcomes (6)

  1. Rapid virologic response

    Measured: Week 4

  2. Early virologic response

    Measured: Week 12

  3. Undetectable HCV RNA

    Measured: Week 24 and Week 48

  4. Normalization of ALT (a liver enzyme)

    Measured: Week 48

  5. Quality of life evaluation

    Measured: throughout the entire study

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

    Measured: Throughout the entire study

Timeline

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

  1. First posted22 Nov 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

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
1,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402428
Sponsor's protocol ID
HGS1008-C1060
Other IDs
ACHIEVE-1
Status last verified
Aug 2013
First submitted
20 Nov 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

  • Zeuzem S, Sulkowski MS, Lawitz EJ, Rustgi VK, Rodriguez-Torres M, Bacon BR, Grigorescu M, Tice AD, Lurie Y, Cianciara J, Muir AJ, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-1 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 1. Gastroenterology. 2010 Oct;139(4):1257-66. doi: 10.1053/j.gastro.2010.06.066. Epub 2010 Jun 27.

    PubMed 20600013

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 165 sites in 15 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 165 sites in United States, Australia, Canada, Germany, France and 10 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 72). 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 NCT00402428, 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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