Status:
COMPLETED
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00298363
Start Date
April 1 2006
End Date
April 1 2011
Last Update
April 25 2013
Active Locations (38)
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1
Pfleger Liver Institute
Los Angeles, California, United States, 90095
2
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
3
University of Miami, Center for Liver Diseases
Miami, Florida, United States, 33136
4
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States, 60612