CClinicalTrials.gg
CompletedNCT00115908Updated Nov 7, 2013

A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

A Phase 2 interventional study of Albuferon and Ribavirin in Hepatitis C, Chronic, sponsored by Human Genome Sciences Inc.. Completed at 87 sites in 8 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-07.

Sponsored by Human Genome Sciences Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
458
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.

02

Conditions studied

  • Hepatitis C, Chronic

Keywords

  • Hepatitis C
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 458 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Human Genome Sciences Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
  • Compensated liver disease

Key Exclusion Criteria:

  • Pregnant or lactating female or males with a pregnant partner.
  • A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
  • A history of moderate, severe or uncontrolled psychiatric disease.
  • A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
458 participants (actual)

Interventions

  • DrugAlbuferon
  • DrugRibavirin
  • DrugPEG-IFNalfa2a
06

What researchers measure

Primary outcomes

  1. Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.

Secondary outcomes

  1. Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.

  2. Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.

  3. Undetectable HCV RNA at Week 24.

  4. End of treatment response (ETR), defined as undetectable HCV RNA at Week 48

07

Study locations

87 sites
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
  • Concord Repatriation General Hospital
    Concord, New South Wales 2139, Australia
  • John Hunter Hospital
    New Lambton Heights, New South Wales 2305, Australia
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Princess Alexandra Hospital
    Brisbane, Queensland 4102, Australia
  • Royal Brisbane Hospital
    Herston, Queensland 4029, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Monash Medical Centre
    Clayton, Victoria 3168, Australia
  • St. Vincents Hospital
    East Melbourne, Victoria 3002, Australia
  • Western Hospital
    Footscray, Victoria 3011, Australia
  • Austin Health
    Heidelberg, Victoria 3081, Australia
  • The Alfred
    Melbourne, Victoria 3004, Australia
  • Royal Melbourne Hospital
    Melbourne, Victoria 3050, Australia
  • Fremantle Hospital
    Fremantle, Western Australia 6160, Australia
  • Sir Charles Gairdner Hospital
    Nedlands, Western Australia 6009, Australia
  • Royal Perth Hospital
    Perth, Western Australia 6000, Australia
  • University of Calgary
    Calgary, Alberta T2N 4N1, Canada
  • University of Alberta
    Edmonton, Alberta T5H 4B9, Canada
  • University of Alberta- Liver Unit
    Edmonton, Alberta T6G 2C8, Canada
  • University of British Columbia
    Vancouver, British Columbia V6T 1Z4, Canada
  • University of Manitoba
    Winnipeg, Manitoba R3E 3P4, Canada
  • Dalhousie University
    Halifax, Nova Scotia B3H2Y9, Canada
  • McMaster Clinic - Hamilton General Hospital
    Hamilton, Ontario L8L 2X2, Canada
  • University of Western Ontario
    London, Ontario N6A5A5, Canada
  • Ottawa Civic Hospital
    Ottawa, Ontario K1S 0W8, Canada
  • Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
  • Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
  • University of Saskatchewan
    Saskatoon, Saskatchewan S7N 0W8, Canada
  • FN Bohunice
    Brno, 62500, Czech Republic
  • Klinika infekcnich nemoci
    Hradec Kralove, 50005, Czech Republic
  • Nemocnice s poliklinikou Melnik
    Melnik, 27601, Czech Republic
  • Slezska nemocnice
    Opava, 74601, Czech Republic
  • Vseobecna fakultni nemocnice
    Prague, 12808, Czech Republic
  • Nuselska poliklinika - Remedis
    Prague, 14000, Czech Republic
  • Fakultni Thomayerova nemocnice
    Prague, 14059, Czech Republic
  • Ambulance pro interni a infekcni nemoci
    Usti nad labem, 40001, Czech Republic
  • University of Angers, CHU Angers
    Angers, 49033, France
  • University of Clichy, Hopital Beaujon
    Clichy, 92110, France
  • University of Creteil, Hopital Henri Mondor
    Creteil, 94010, France
  • University of Grenoble, Hopital Nord
    Grenoble, 38043, France
  • University of Lille, Hopital Claude Huriez
    Lille, 59037, France
  • University of Lyon, Hopital de l'Hotel Dieu
    Lyon, 69288, France
  • University of Marseille, Hopital Saint Joseph
    Marseille, 13285, France
  • University of Nice, Hopital de l'Archet
    Nice, 06202, France
  • University of Orleans, Hopital de la Source
    Orleans, 45100, France
  • University of Paris, Hopital Saint-Antoine
    Paris, 75012, France
  • University of Paris, Hopital Pitie-Salpetriere
    Paris, 75013, France
  • University of Paris, Hopital Necker
    Paris, 75743, France
  • Hopital Haut-Leveque
    Pessac, 33600, France
  • University of Toulouse, Clinique Dieulafoy
    Toulouse, 31059, France
  • Hopital de Brabois
    Vandoeuvre, 54511, France
  • University of Berlin, Charite Campus Virchow Klinikum
    Berlin, 13353, Germany
  • University of Bochum, Kliniken Bergmannsheil
    Bochum, 44892, Germany
  • University of Duesseldorf
    Duesseldorf, 40255, Germany
  • University of Essen
    Essen, 45122, Germany
  • University of Frankfurt
    Frankfurt, 60590, Germany
  • University of Freiburg
    Freiburg, 79106, Germany
  • University of Hamburg, Hospital Hamburg Eppendorf
    Hamburg, 20246, Germany
  • University of Hannover
    Hannover, 30625, Germany
  • University of Heidelberg
    Heidelberg, 69120, Germany
  • University of Saarland
    Homburg, 66421, Germany
  • University of Kiel
    Kiel, 24105, Germany
  • University of Leipzig
    Leipzig, 04103, Germany
  • University of Mainz
    Mainz, 55131, Germany
  • University of Tuebingen
    Tuebingen, 72076, Germany
  • B´nai-Zion Medical Center
    Haifa, 31048, Israel
  • Rambam Medical Center
    Haifa, 31096, Israel
  • Hadassah Medical Organization
    Jerusalem, 91120, Israel
  • Holy Family Hospital
    Nazareth, 16100, Israel
  • Rabin Medical Center, Beilinson Campus
    Petah Tiqwa, 49100, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
  • Oddzial Chorob Watroby
    Bialystok, 15-540, Poland
  • Katedra i Klinika Chorob Zakaznych i Hepatologii
    Bydgoszcz, 85-030, Poland
  • Katedra i Oddzial Kliniczny Chorob Zakaznych
    Chorzow, 41-500, Poland
  • Wojewodzki Szpital Zespolony
    Kielce, 24-317, Poland
  • Szpital Uniwersytecki w Krakowie
    Krakow, 31-531, Poland
  • Klinika Obserwacyjno Zakazna
    Lodz, 91-347, Poland
  • Oddzial Zakazny
    Poznan, 61-003, Poland
  • Katedra i Klinika Chorob Zakaznych
    Szczecin, 71-455, Poland
  • I Oddzial Dzienny SPZOZ
    Warsaw, 01-201, Poland
  • Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
    Warsaw, 01-201, Poland
  • Katedra i Klinika Chorob Zakaznych
    Wroclaw, 51-149, Poland
  • Spitalul Clinic Colentina
    Bucharest, 20125, Romania
  • Institutul Clinic Fundeni
    Bucharest, 22328, Romania
  • Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
    Bucharest, 30303, Romania
  • Spitalul Clinic de Adulti Cluj-Napoca
    Cluj-Napoca, 400162, Romania
  • Institutul de Gastroenterologie si Hepatologie
    Iasi, 700111, Romania
08

References and documents

Publications

  • Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naive patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11. PubMed 19447518 ↗
  • Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403. PubMed 18666223 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00115908
Lead sponsor
Human Genome Sciences Inc.
Responsible party
Sponsor
First posted
Jun 27, 2005
Start date
May 2005
Primary completion
May 2007
Completion
May 2007
Last update
Nov 7, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion