Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C
1 other identifier
interventional
525
12 countries
55
Brief Summary
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 16, 2016
April 1, 2011
2.2 years
September 23, 2008
November 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
at every visit
Secondary Outcomes (1)
Viral load
at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.
Study Arms (5)
alb-interferon arm 1
EXPERIMENTALalb-interferon arm 2
EXPERIMENTALalb-interferon arm 3
EXPERIMENTALalb-interferon arm 4
EXPERIMENTALpeg-interferon
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age of 18 years or older
- Clinical diagnosis of chronic hepatitis C
- Infection with HCV genotype 2 or 3
- No previous IFNα-based therapy
You may not qualify if:
- Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
- Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
- History or current evidence of decompensated liver disease; other forms of liver disease
- Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of moderate, severe or uncontrolled psychiatric disease
- History of seizure disorder
- History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
- Clinically significant findings on eye/retinal examination
- History of immunologically mediated disease
- Organ transplantation other than cornea or hair transplant
- History of clinically significant hemoglobinopathy
- Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
- History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Human Genome Sciences Inc.collaborator
Study Sites (55)
Novartis Investigative site
Clayton, Australia
Novartis Investigative site
Fitzroy, Australia
Novartis Investigative site
Greenslopes, Australia
Novartis Investigative site
Kingswood, Australia
Novartis Investigative site
Melbourne, Australia
Novartis Investigative site
Westmead, Australia
Novartis Investigative site
Calgary, Canada
Novartis Investigative Site
Downsview, Canada
Novartis Investigative site
Montreal, Canada
Novartis Investigative site
Toronto, Canada
Novartis Investigative site
Vancouver, Canada
Novartis Investigative Site
Cretail, France
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative site
Düsseldorf, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Heraklion, Greece
Novartis Investigative Site
Loannina, Greece
Novartis Investigative Site
Patra-Rio, Greece
Novartis Investigative Site
Piraeurs, Greece
Novartis Investigative Site
Thessaloniki, Greece
Novartis Investigative Site
Chandigarh, India
Novartis Investigative site
Hyderabad, India
Novartis Investigative Site
Lucknow, India
Novartis Investigative Site
Ludhiana, India
Novartis Investigative Site
Mumbai, India
Novartis Investigative Site
New Delhi, India
Novartis Investigative site
Bologna, Italy
Novartis Investigative site
Milan, Italy
Novartis Investigative site
Napoli, Italy
Novartis Investigative site
Pavia, Italy
Novartis Investigative site
Pisa, Italy
Novartis Investigative site
Polermo, Italy
Novartis Investigative site
Torino, Italy
Novartis Investigative site
Bialystok, Poland
Novartis Investigative site
Lodz, Poland
Novartis Investigative site
Barcelona, Spain
Novartis Investigative site
Madrid, Spain
Novartis Investigative site
Málaga, Spain
Novartis Investigative site
Oviedo, Spain
Novartis Investigative site
Seville, Spain
Novartis Investigative site
Valencia, Spain
Novartis Investigative site
Kaohsiung City, Taiwan
Novartis Investigative site
Tainan, Taiwan
Novartis Investigative site
Taipei, Taiwan
Novartis Investigative site
Bangkok, Thailand
Novartis Investigative site
Chaingmai, Thailand
Novartis Investigative Site
Hat Yai, Thailand
Novartis Investigative Site
Muang, Thailand
Novartis Investigative Site
Glasgow, United Kingdom
Related Publications (1)
Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.
PMID: 22863266RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2008
First Posted
September 25, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 16, 2016
Record last verified: 2011-04