Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00371150

Purpose

The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in patients who are either of Black/African-American race or of Hispanic ethnicity.

Condition	Intervention	Phase
Hepatitis B Infection	Drug: Entecavir	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Entecavir

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:

A Study to Describe the Antiviral Effect of Entecavir (ETV) in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection Who Are Nucleoside-Naive

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The proportion of subjects who achieve a virologic response, defined as HBV DNA < 50 IU/mL (approximately 300 copies/mL) [ Time Frame: at Week 48 of ETV treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the proportions of subjects meeting the following endpoints [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
HBV DNA < lower limit of detection [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Mean reduction from baseline in HBV DNA [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Proportion with ALT normalization (≤ 1 x ULN) [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Proportions with confirmed HBeAg loss and HBe seroconversion; and confirmed HBsAg loss and HBs seroconversion (for HBeAg-positive cohort only) [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
Number and percent of subjects with adverse events (AEs), serious AEs (SAEs), laboratory abnormalities and discontinuations due to AEs. [ Time Frame: at Week 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

80

Study Start Date:

November 2006

Estimated Study Completion Date:

January 2011

Estimated Primary Completion Date:

July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator	Drug: Entecavir Tablets, Oral, 0.5 mg, once daily, up to 48 weeks

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Chronic HBV infection, with either HBeAg-positive (HBeAb-negative) or HBeAg-negative (HBeAb-positive) disease
Black/African American Race and/or Hispanic ethnicity
Nucleoside/tide-naive
Males or females ≥ 16 years of age (or minimum age required in a given country)
Compensated liver function
HBV DNA HBe-negative > 10^4 copies/mL HBe-positive > 10^5 copies/mL
ALT of 1.3 to 10 x ULN
No Co-infection with HIV, HCV or HDV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371150

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.