Clinical trial NCT00298363 (phase 2, status: completed)
Conditions: chronic hepatitis b
ICD codes: B18.0, B18.1, B18.2, B18.8, B18.9
Drugs: tenofovir disoproxil fumarate (tenofovir df; tdf), emtricitabine/tenofovir disoproxil fumarate (ftc/tdf), entecavir (etv), tdf placebo, ftc/tdf placebo, etv placebo
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Eligibility criteria:

        Inclusion Criteria:

        A participant was required to meet all of the following inclusion criteria to be eligible
        for participation in the study:

          -  Chronic Hepatitis B infection

          -  18 through 69 years of age, inclusive

          -  HBV DNA ≥ 1000 copies/mL

          -  Decompensated liver disease with all of the following:

               -  CPT score of 7-12 (inclusive) OR history of CPT score ≥ 7 and any CPT at screen ≤
                  12

               -  Serum alanine aminotransferase (ALT) < 10 x the upper limit of the normal range
                  (ULN)

               -  Hemoglobin ≥ 7.5 g/dL

               -  Total white blood cell (WBC) count ≥ 1,500/mm^3

               -  Platelet count ≥ 30,000/mm^3

          -  Alpha-fetoprotein ≤ 20 ng/mL and ultrasound or other imaging with no evidence of
             hepatocellular carcinoma (HCC), or alpha-fetoprotein of 21-50 ng/mL and computed
             tomography (CT)/magnetic resonance imaging (MRI) scan with no evidence of HCC, within
             6 months of screening

          -  Calculated creatinine clearance ≥ 50 mL/min

          -  Negative human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis D
             virus (HDV) serologies

          -  Less than 24 months of total prior adefovir dipivoxil exposure

          -  Willing and able to provide written informed consent

        Exclusion Criteria:

        A participant who met any of the following exclusion criteria could not be enrolled in the
        study:

          -  Pregnant women, women who were breastfeeding or who believed they may have wished to
             become pregnant during the course of the study

          -  Males and females of reproductive potential who were unwilling to use an effective
             method of contraception during the study

          -  Prior use of TDF or ETV

          -  History of variceal bleeding, hepatorenal syndrome, Grade 3 or 4 hepatic
             encephalopathy, or spontaneous bacterial peritonitis within 60 days of screening

          -  Grade 2 hepatic encephalopathy at screening

          -  History of solid organ or bone marrow transplant

          -  Current use of hepatotoxic drugs, nephrotoxic drugs, or drugs that interfere with
             renal tubular secretion

          -  Current therapy with immunomodulators (eg, corticosteroids, interleukin-2, etc.) or
             investigational drugs

          -  Diagnosis of proximal tubulopathy

          -  Use of investigational agent within 30 days prior to screening

          -  Known hypersensitivity to TDF, FTC, ETV, or formulation excipients of any of the study
             drug products