Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–69
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
