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Sponsored by: |
Bristol-Myers Squibb |
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00065507 |
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
Condition | Intervention | Phase |
Hepatitis B |
Drug: Entecavir Drug: Adefovir |
Phase III |
MedlinePlus related topics: | Hepatitis Hepatitis B |
ChemIDplus related topics: | Hepatitis B Vaccines Adefovir dipivoxil Adefovir Entecavir |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation |
Estimated Enrollment: | 220 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A1: Experimental |
Drug: Entecavir
Tablets, Oral, ETV = 1 mg once daily, 96 weeks from the time the last patient is randomized
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A2: Active Comparator |
Drug: Adefovir
Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Show 44 Study Locations |
Bristol-Myers Squibb |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
BMS Clinical Trials Disclosure 
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For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 
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Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI463-048 |
First Received: | July 28, 2003 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00065507 |
Health Authority: | United States: Food and Drug Administration |
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