A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
NCT ID: NCT00057265
Last Updated: 2015-03-20
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
PHASE3
INTERVENTIONAL
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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telbivudine or lamivudine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2.
* Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time
* Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
16 Years
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Novartis
INDUSTRY
Locations
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Los Angeles, California, United States
Orange, California, United States
San Diego, California, United States
Hackensack, New Jersey, United States
Houston, Texas, United States
Seoul, , South Korea
Barcelona, , Spain
Valencia, , Spain
Bangkok, , Thailand
Istanbul, , Turkey (Türkiye)
London, , United Kingdom
Countries
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References
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Zeuzem S, Gane E, Liaw YF, Lim SG, DiBisceglie A, Buti M, Chutaputti A, Rasenack J, Hou J, O'Brien C, Nguyen TT, Jia J, Poynard T, Belanger B, Bao W, Naoumov NV. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B. J Hepatol. 2009 Jul;51(1):11-20. doi: 10.1016/j.jhep.2008.12.019. Epub 2009 Feb 12.
Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y, Chen Y, Heathcote EJ, Rasenack J, Bzowej N, Naoumov NV, Di Bisceglie AM, Zeuzem S, Moon YM, Goodman Z, Chao G, Constance BF, Brown NA; Globe Study Group. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007 Dec 20;357(25):2576-88. doi: 10.1056/NEJMoa066422.
Other Identifiers
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NV-02B-007
Identifier Type: -
Identifier Source: org_study_id
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