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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00411385




Registration number
NCT00411385
Ethics application status
Date submitted
13/12/2006
Date registered
14/12/2006
Date last updated
8/08/2013

Titles & IDs
Public title
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
Scientific 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.
Secondary ID [1] 0 0
ACHIEVE-2/3
Secondary ID [2] 0 0
HGS1008-C1067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - albumin interferon alfa-2b
Treatment: Drugs - peginterferon alfa-2a
Treatment: Drugs - Ribavirin

Experimental: 1 - 900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day

Experimental: 2 - 1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day

Active comparator: 3 - 180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day


Treatment: Drugs: albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks

Treatment: Drugs: peginterferon alfa-2a
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks

Treatment: Drugs: Ribavirin
800mg/day for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sustained virologic response (SVR)
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Rapid virologic response
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Early virologic response
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Undetectable HCV RNA
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Normalization of ALT (a liver enzyme)
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Quality of life evaluation
Timepoint [5] 0 0
Week 48
Secondary outcome [6] 0 0
Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)
Timepoint [6] 0 0
Througout the entire treatment period

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
933
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
St George Hospital Clinical School of Medicine - Kogarah
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Gallipoli Research Foundation and Greenslopes Private Hospital - Greenslopes
Recruitment hospital [7] 0 0
Royal Bribane & Women's Hospital - Herston
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
St Vincent's Hospital - Fitzroy, Victoria
Recruitment hospital [11] 0 0
Western Hospital - Footscray
Recruitment hospital [12] 0 0
Austin Hospital - Heidelburg
Recruitment hospital [13] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2305 - New Lambton
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy, Victoria
Recruitment postcode(s) [11] 0 0
3011 - Footscray
Recruitment postcode(s) [12] 0 0
3081 - Heidelburg
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Belgium
State/province [19] 0 0
Brussels
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Liège
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Brazil
State/province [23] 0 0
BA
Country [24] 0 0
Brazil
State/province [24] 0 0
SP
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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France
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Clichy
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France
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Creteil
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France
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Lyon Cedex 02
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France
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Marseille Cedex 08
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France
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Orleans
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France
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Paris
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France
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Pessac cedex
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France
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Toulouse Cedex
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France
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Vandoeuvre
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Germany
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Berlin
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Germany
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Duesseldorf
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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Frankfurt / Main
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Germany
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Freiburg
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Germany
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Hannover
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Germany
State/province [46] 0 0
Heidelberg
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Germany
State/province [47] 0 0
Leipzig
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Germany
State/province [48] 0 0
Mainz
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Germany
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Marl
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India
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Ludhiana
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India
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Mumbai
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India
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New Delhi
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Nazareth
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Korea, Republic of
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Bundang
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Korea, Republic of
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Daegu
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seonnam City
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Malaysia
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Alor Setar
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Malaysia
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Kuala Lumpur
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Malaysia
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Selangor
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Mexico
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CP
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Mexico
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DF
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Mexico
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Mexico City
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Poland
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Bialystok
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Poland
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Czeladz
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Warszawa
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Poland
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Wroclaw
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Puerto Rico
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Santurce
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Singapore
State/province [78] 0 0
Singapore
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Spain
State/province [79] 0 0
Badalona - Barcelona
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Malmö
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Sweden
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Stockholm
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Taiwan
State/province [86] 0 0
R.o.c.
Country [87] 0 0
Taiwan
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Changhua
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Taiwan
State/province [88] 0 0
Taichung
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Taiwan
State/province [89] 0 0
Tainan
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taipei
Country [91] 0 0
Thailand
State/province [91] 0 0
Bangkok
Country [92] 0 0
Thailand
State/province [92] 0 0
Chiang Mai
Country [93] 0 0
United Kingdom
State/province [93] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Human Genome Sciences Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novartis
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00411385
Trial related presentations / 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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00411385