Hepatitis C, ChronicPhase 2NCT00115908
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
A Phase 2 study testing Albuferon, Ribavirin and PEG-IFNalfa2a in people with Hepatitis C, Chronic, run by Human Genome Sciences Inc. at 87 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Albuferon, Ribavirin and PEG-IFNalfa2a
- How many people
- 458 participants
- Where
- 87 sitesin 8 countries
- Study dates
- May 2005to May 2007
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
- Compensated liver disease
Who cannot join
- 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.
Trial locations and contacts
87 sites in 8 countries.
87 sites in 8 countries
Australia16 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Princess Alexandra Hospital
Brisbane, Queensland, 4102
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. Vincents Hospital
East Melbourne, Victoria, 3002
Western Hospital
Footscray, Victoria, 3011
Fremantle Hospital
Fremantle, Western Australia, 6160
Austin Health
Heidelberg, Victoria, 3081
Royal Brisbane Hospital
Herston, Queensland, 4029
The Alfred
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Royal Perth Hospital
Perth, Western Australia, 6000
Westmead Hospital
Westmead, New South Wales, 2145
France15 sites
University of Angers, CHU Angers
Angers, 49033
University of Clichy, Hopital Beaujon
Clichy, 92110
University of Creteil, Hopital Henri Mondor
Créteil, 94010
University of Grenoble, Hopital Nord
Grenoble, 38043
University of Lille, Hopital Claude Huriez
Lille, 59037
University of Lyon, Hopital de l'Hotel Dieu
Lyon, 69288
University of Marseille, Hopital Saint Joseph
Marseille, 13285
University of Nice, Hopital de l'Archet
Nice, 06202
University of Orleans, Hopital de la Source
Orléans, 45100
University of Paris, Hopital Saint-Antoine
Paris, 75012
University of Paris, Hopital Pitie-Salpetriere
Paris, 75013
University of Paris, Hopital Necker
Paris, 75743
Hopital Haut-Leveque
Pessac, 33600
University of Toulouse, Clinique Dieulafoy
Toulouse, 31059
Hopital de Brabois
Vandœuvre-lès-Nancy, 54511
Germany14 sites
University of Berlin, Charite Campus Virchow Klinikum
Berlin, 13353
University of Bochum, Kliniken Bergmannsheil
Bochum, 44892
University of Duesseldorf
Düsseldorf, 40255
University of Essen
Essen, 45122
University of Frankfurt
Frankfurt, 60590
University of Freiburg
Freiburg im Breisgau, 79106
University of Hamburg, Hospital Hamburg Eppendorf
Hamburg, 20246
University of Hannover
Hanover, 30625
University of Heidelberg
Heidelberg, 69120
University of Saarland
Homburg, 66421
University of Kiel
Kiel, 24105
University of Leipzig
Leipzig, 04103
University of Mainz
Mainz, 55131
University of Tuebingen
Tübingen, 72076
Canada12 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta, T5H 4B9
University of Alberta- Liver Unit
Edmonton, Alberta, T6G 2C8
Dalhousie University
Halifax, Nova Scotia, B3H2Y9
McMaster Clinic - Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
University of Western Ontario
London, Ontario, N6A5A5
Ottawa Civic Hospital
Ottawa, Ontario, K1S 0W8
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
University of Manitoba
Winnipeg, Manitoba, R3E 3P4
Poland11 sites
Oddzial Chorob Watroby
Bialystok, 15-540
Katedra i Klinika Chorob Zakaznych i Hepatologii
Bydgoszcz, 85-030
Katedra i Oddzial Kliniczny Chorob Zakaznych
Chorzów, 41-500
Wojewodzki Szpital Zespolony
Kielce, 24-317
Szpital Uniwersytecki w Krakowie
Krakow, 31-531
Klinika Obserwacyjno Zakazna
Lodz, 91-347
Oddzial Zakazny
Poznan, 61-003
Katedra i Klinika Chorob Zakaznych
Szczecin, 71-455
I Oddzial Dzienny SPZOZ
Warsaw, 01-201
Klinika Hepatologii i Nabytych Niedoborow Immunologicznych
Warsaw, 01-201
Katedra i Klinika Chorob Zakaznych
Wroclaw, 51-149
Czechia8 sites
FN Bohunice
Brno, 62500
Klinika infekcnich nemoci
Hradec Králové, 50005
Nemocnice s poliklinikou Melnik
Mělník, 27601
Slezska nemocnice
Opava, 74601
Vseobecna fakultni nemocnice
Prague, 12808
Nuselska poliklinika - Remedis
Prague, 14000
Fakultni Thomayerova nemocnice
Prague, 14059
Ambulance pro interni a infekcni nemoci
Ústí nad Labem, 40001
Israel6 sites
B´nai-Zion Medical Center
Haifa, 31048
Rambam Medical Center
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
Romania5 sites
Spitalul Clinic Colentina
Bucharest, 20125
Institutul Clinic Fundeni
Bucharest, 22328
Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"
Bucharest, 30303
Spitalul Clinic de Adulti Cluj-Napoca
Cluj-Napoca, 400162
Institutul de Gastroenterologie si Hepatologie
Iași, 700111
About this study
Official title: A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Albuferon, Ribavirin, PEG-IFNalfa2a
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuferonDrug
RibavirinDrug
PEG-IFNalfa2aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
Secondary outcomes (4)
Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Undetectable HCV RNA at Week 24.
End of treatment response (ETR), defined as undetectable HCV RNA at Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115908
- Sponsor's protocol ID
- ALFR-HC-04
- Status last verified
- Nov 2013
- First submitted
- 26 Jun 2005
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 19447518Zeuzem 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
- ClinicalTrials.gov ID
- NCT00115908
- Acronym / sponsor ID
- ALFR-HC-04
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Human Genome Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 27 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
- Compensated liver disease
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuferon | Drug | – |
| Ribavirin | Drug | – |
| PEG-IFNalfa2a | Drug | – |
Primary outcome
Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
4 secondary outcomes
Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Undetectable HCV RNA at Week 24.
End of treatment response (ETR), defined as undetectable HCV RNA at Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
- Derived from this study: PubMed 19447518Neumann 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.
- Derived from this study: PubMed 18666223Zeuzem 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
87 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albuferon, Ribavirin and PEG-IFNalfa2a in people with Hepatitis C, Chronic, run by Human Genome Sciences Inc. at 87 sites in 8 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 2 inclusion and 4 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 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in Australia, France, Germany, Canada, Poland and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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), defined as undetectable HCV RNA at 24 weeks after the end of therapy.. 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 NCT00115908, which also lists 2 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 7 Nov 2013.