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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Hepatitis B Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

Tablets, Oral, 0.5 mg, once daily, up to 52 weeks

Interventions

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Entecavir

Tablets, Oral, 0.5 mg, once daily, up to 52 weeks

Intervention Type DRUG

Other Intervention Names

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Baraclude BMS-200475

Eligibility Criteria

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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
* ALT of 1.3 to 10 x upper limit of normal (ULN)
* No Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV)

Exclusion Criteria

* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks after study medication has been discontinued
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment or prior to study drug administration
* Evidence of decompensated cirrhosis including but not limited to: variceal bleeding; hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis
* Recent history of pancreatitis (resolution of any recent pancreatitis must be documented by normal lipase at least 12 weeks prior to the first dose of study medication)
* Currently abusing illegal drugs or alcohol sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
* Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
* Serum creatinine \> 1.5 mg/dL
* Hemoglobin \< 10.0 g/dL
* Platelet count \< 70,000/mm3
* Absolute neutrophil count \< 1200 cells/mm3
* Serum alpha fetoprotein (AFP) level \> 100 ng/mL. If the AFP level is between 21 and 100 ng/mL, it must be repeated. If the repeat AFP level is between 21 and 100 ng/mL and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose of study medication does not demonstrate a focal lesion suggestive of carcinoma, the subject may be dosed in the study
* Known history of allergy to nucleoside analogues
* Any prior therapy with Entecavir
* Any prior or concomitant use of nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., ETV, lamivudine (LVD), tenofovir \[TDF\], emtricitabine (FTC), clevudine, telbivudine \[LdT\], famciclovir), or any other experimental anti-HBV antiviral agent
* Therapy with interferon, thymosin alpha or other immunostimulators within 24 weeks of enrollment (i.e., dosing) into this study
* Subjects who require chronic administration of concomitant medications which cause immunosuppression or which are associated with a high rate of nephrotoxicity or hepatotoxicity, or which affect renal excretion, should not be enrolled in this study
* Unable to tolerate oral medication
* Poor peripheral venous access
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No