Status:
COMPLETED
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
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 ethni...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00371150
Start Date
November 1 2006
End Date
March 1 2011
Last Update
April 16 2012
Active Locations (27)
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1
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States, 36116
2
University Of Arizona
Tucson, Arizona, United States, 85724
3
George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
4
University Of Miami
Miami, Florida, United States, 33136