Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation - Tabular View

Tracking Information

First Received Date ^ICMJE

July 28, 2003

Last Updated Date

November 4, 2009

Start Date ^ICMJE

August 2003

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean serum HBV DNA PCR adjusted for baseline [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Mean serum HBV DNA PCR at Week 24 adjusted for baseline

Change History

Complete list of historical versions of study NCT00065507 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Discontinuation or dose reduction of study drug due to clinical AE or lab abnormality. Confirmed nephrotoxicity, defined as a < or equal to mg/dL increase in serum creatinine compared w/ baseline [ Time Frame: on 2 sequential measure ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Official Title ^ICMJE

Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatitis B

Intervention ^ICMJE

Drug: Entecavir
Drug: Adefovir

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.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

220

Estimated Completion Date

May 2013

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion

CP score >= 7
HBV viremia

Exclusion

ALT > 15 x ULN
HIV/HCV/HDV coinfection

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, Canada, Greece, Hong Kong, India, Indonesia, Italy, Philippines, Poland, Russian Federation, Singapore, South Africa, Taiwan, Thailand, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00065507

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

AI463-048

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP