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Tracking Information | |
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First Received Date † | January 20, 2004 |
Last Updated Date | January 23, 2008 |
Start Date † | December 2003 |
Current Primary Outcome Measures † |
Primary Outcome is a composite endpoint termed Clinical Response, defined as achievement of the following three efficacy criteria: Serum HBV DNA < 4 log10 copies/mL, Normal ALT level, Improvement or stabilization in CTP score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00076336 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
Time to Clinical Response; Duration of Clinical Response; Improvement, Stabilization, and Worsening in CTP score; Improvement, Stabilization, and Worsening in a modified (3-component) CTP score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis |
Official Title † | Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis |
Brief Summary | This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine. |
Detailed Description | |
Study Phase | Phase III |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Active, not recruiting |
Enrollment † | 232 |
Completion Date | |
Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
Other protocol-defined inclusion criteria may apply. Exclusion Criteria:
Other protocol-defined exclusion criteria may apply. |
Gender | Both |
Ages | 16 Years to 70 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States, Australia, Canada, China, France, Germany, India, Israel, Korea, Republic of, Latvia, Malaysia, New Zealand, Poland, Russian Federation, Singapore, Spain, Taiwan, Thailand, Turkey, United Kingdom, Vietnam |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00076336 |
Responsible Party | Novartis |
Secondary IDs †† | |
Study Sponsor † | Novartis |
Collaborators †† | |
Investigators † | |
Information Provided By | Novartis |
Verification Date | January 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |