Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
NCT ID: NCT01204762
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
197 participants
INTERVENTIONAL
2010-11-30
2013-12-31
Brief Summary
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Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in combination with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A Arm 1: pegIFN (180 μg)
pegIFN
Syringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks
Part A Arm 2: pegIFNα-2a
pegIFNα-2a
Syringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks
Part B: pegIFN lambda + Entecavir
PegIFN lambda
Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks
Entecavir
Tablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda
Interventions
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pegIFNα-2a
Syringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks
PegIFN lambda
Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks
Entecavir
Tablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda
pegIFN
Syringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between the ages of 18 and 70
* Have not been previously treated with an interferon
* HBV nucleos(t)ide-naive
Exclusion Criteria
* Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease
* Able to tolerate oral medication
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
Sc Clinical Research, Inc.
Garden Grove, California, United States
University Of California, Davis Medical Center
Sacramento, California, United States
Research And Education, Inc.
San Diego, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Atlanta Gastroenterology Associates, Llc
Atlanta, Georgia, United States
Mercy Medical Center
Baltimore, Maryland, United States
Gastro Center Of Maryland
Colombia, Maryland, United States
Medical Procare, Pllc
Flushing, New York, United States
Office Of Sing Chan Md
Flushing, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Local Institution
Camperdown, New South Wales, Australia
Local Institution
Liverpool, New South Wales, Australia
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Westmead Nsw, New South Wales, Australia
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Clayton Vic, Victoria, Australia
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Heidelberg Vic, Victoria, Australia
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Melbourne, Victoria, Australia
Local Institution
Fremantle, Western Australia, Australia
Heritage Medical Research Clinic, University Of Calgary
Calgary, Alberta, Canada
Local Institution
Winnipeg, Manitoba, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Western Hospital University Health Network
Toronto, Ontario, Canada
Local Institution
Clichy, , France
Local Institution
Nice, , France
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Paris, , France
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Rennes, , France
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Tübingen, , Germany
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Tai Po, , Hong Kong
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Florence, , Italy
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Roma, , Italy
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Rotterdam, , Netherlands
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Singapore, , Singapore
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Singapore, , Singapore
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Chuncheon, , South Korea
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Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Kaohsiung City, , Taiwan
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Taichung, , Taiwan
Local Institution
Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
Local Institution
Taoyuan District, , Taiwan
Countries
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References
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Phillips S, Mistry S, Riva A, Cooksley H, Hadzhiolova-Lebeau T, Plavova S, Katzarov K, Simonova M, Zeuzem S, Woffendin C, Chen PJ, Peng CY, Chang TT, Lueth S, De Knegt R, Choi MS, Wedemeyer H, Dao M, Kim CW, Chu HC, Wind-Rotolo M, Williams R, Cooney E, Chokshi S. Peg-Interferon Lambda Treatment Induces Robust Innate and Adaptive Immunity in Chronic Hepatitis B Patients. Front Immunol. 2017 May 29;8:621. doi: 10.3389/fimmu.2017.00621. eCollection 2017.
Chan HLY, Ahn SH, Chang TT, Peng CY, Wong D, Coffin CS, Lim SG, Chen PJ, Janssen HLA, Marcellin P, Serfaty L, Zeuzem S, Cohen D, Critelli L, Xu D, Wind-Rotolo M, Cooney E; LIRA-B Study Team. Peginterferon lambda for the treatment of HBeAg-positive chronic hepatitis B: A randomized phase 2b study (LIRA-B). J Hepatol. 2016 May;64(5):1011-1019. doi: 10.1016/j.jhep.2015.12.018. Epub 2015 Dec 29.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-020387-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-005
Identifier Type: -
Identifier Source: org_study_id
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