Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
Condition: Hepatitis B Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Entecavir
Intervention description: Tablets, Oral, 0.5 mg, once daily, up to 52 weeks
Intervention MeSH terms: Entecavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

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 ethnicity.
    

Eligibility 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

          -  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