Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
NCT ID: NCT00076336
Last Updated: 2011-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
232 participants
INTERVENTIONAL
2003-12-31
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
QUADRUPLE
Study Groups
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Telbivudine 600 mg
Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
Telbivudine
600mg/day oral tablet for 104 weeks
Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
Lamivudine 100 mg
Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
Lamivudine
100mg/day oral tablet for 104 weeks
Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
Interventions
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Telbivudine
600mg/day oral tablet for 104 weeks
Lamivudine
100mg/day oral tablet for 104 weeks
Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of hepatic cirrhosis or portal hypertension.
Exclusion Criteria
* Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
* Patient previously received lamivudine, adefovir, or an investigational anti-hepatitis B virus (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
Responsible Party
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Novartis Pharmaceuticals
Locations
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Phoenix, Arizona, United States
Los Angeles, California, United States
Denver, Colorado, United States
Indianapolis, Indiana, United States
Rochester, Minnesota, United States
New York, New York, United States
Houston, Texas, United States
Madison, Wisconsin, United States
Heidelburg, , Australia
Winnipeg, , Canada
Hong Kong, , China
Villejuif, , France
Hanover, , Germany
Novartis
New Delhi, , India
Tel Aviv, , Israel
Novartis
Riga, , Latvia
Novartis
Kuala Lumpur, , Malaysia
Auckland, , New Zealand
Novartis
Krakow, , Poland
Novartis
Moscow, , Russia
Singapore, , Singapore
Seoul, , South Korea
Barcelona, , Spain
Taipei, , Taiwan
Bangkok, , Thailand
Novartis
Istanbul, Istanbul, Turkey (Türkiye)
London, , United Kingdom
Novartis
Hanoi, , Vietnam
Countries
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References
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E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. Chutaputti, R. Safadi, T. Tanwandee, S. Thongsawat, N. Assy, S.K. Sarin, W. Bao, A. Trylesinski, C. Avila. TREATMENT OF DECOMPENSATED HBV-CIRRHOSIS: RESULTS FROM 2-YEARS RANDOMIZED TRIAL WITH TELBIVUDINE OR LAMIVUDINE. Journal of Hepatology 52, Supplement 1, Page S4. April 2010
Other Identifiers
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CLDT600A2301
Identifier Type: -
Identifier Source: org_study_id
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