Suboptimal Responders to Adefovir Switching to Entecavir - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00718887

Purpose

Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: Entecavir Drug: Adefovir Switching to Entecavir	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Adefovir dipivoxil Adefovir Entecavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Comparative Study of the Week 12 Antiviral Efficacy and Safety of Switching to Entecavir vs. Continuing Adefovir Treatment in Adults With Chronic Hepatitis B and Suboptimal Response to Adefovir

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Percent of HBV DNA < 50 IU/mL [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of HBV DNA < 50 IU/mL [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Mean reduction of HBV DNA [ Time Frame: at Weeks 12 & 48 ] [ Designated as safety issue: No ]
Percentage of subjects with ALT normalization [ Time Frame: at Weeks 12 & 48 ] [ Designated as safety issue: No ]
Percentage of HBeAg loss, seroconversion, HBsAg loss and seroconversion [ Time Frame: at Weeks 12 & 48 ] [ Designated as safety issue: No ]
Safety [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Resistance [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental	Drug: Entecavir Tablets, Oral, 0.5, once daily, 52 weeks
II Control	Drug: Adefovir Switching to Entecavir Tablets, Oral, 10 mg Adefovir, 0.5 Entecavir, once daily, 12 weeks Adefovir Treatment, followed by Entecavir treatment until 52 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Chronic HBV infection with HBeAg-positive or negative disease
Naïve to nucleoside/nucleotide analogues except for Adefovir
Suboptimal responders to Adefovir treatment
No LVD/LdT, Entecavir or Adefovir resistance associated substitutions at screening
Males or females ≥ 16 years of age
Compensated liver function
Serum ALT <10 × ULN

Exclusion Criteria:

Women who are pregnant or breastfeeding
Evidence of decompensated cirrhosis
Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718887

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

China
Local Institution	Recruiting
Beijing, China, 100011
Contact: Site 002
Local Institution	Recruiting
Shanghai, China, 200235
Contact: Site 001
Local Institution	Recruiting
Shanghai, China
Contact: Site 008
China, Guizhou
Local Institution	Recruiting
Guiyang, Guizhou, China, 550004
Contact: Site 003
China, Jiangsu
Local Institution	Not yet recruiting
Nanjing, Jiangsu, China, 210002
Contact: Site 005
China, Jiangxi
Local Institution	Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Site 004
China, Jilin
Local Institution	Not yet recruiting
Changchun, Jilin, China, 130021
Contact: Site 006
China, Liaoning
Local Institution	Not yet recruiting
Shenyang, Liaoning, China, 110004
Contact: Site 007

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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:	AI463-171
Study First Received:	July 17, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00718887
Health Authority:	China: State Food and Drug Administration

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 January 13, 2009