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

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	August 2003
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (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
A2: Active Comparator	Drug: Adefovir Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion

CP score >= 7
HBV viremia

Exclusion

ALT > 15 x ULN
HIV/HCV/HDV coinfection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065507

Show 45 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI463-048
First Received:	July 28, 2003
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00065507
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

hepatic decompensation

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Entecavir

Digestive System Diseases

Hepatitis, Chronic

Hepatitis B, Chronic

Hepatitis B

Hepatitis, Viral, Human

Adefovir dipivoxil

DNA Virus Infections

Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Retroviral Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Antiviral Agents

Hepadnaviridae Infections

Nucleic Acid Synthesis Inhibitors

Pharmacologic Actions

Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00065507