Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
NCT ID: NCT00298363
Last Updated: 2013-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2006-04-30
2011-04-30
Brief Summary
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A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of \< 2 log\_10 copies/mL and plasma HBV DNA \> 10,000 copies/mL (or plasma HBV DNA \> 1,000 copies/mL for subjects who entered the study with HBV DNA \< 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining \> 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tenofovir DF
TDF 300 mg + FTC/TDF placebo + ETV placebo once daily (QD)
Tenofovir disoproxil fumarate (tenofovir DF; TDF)
300-mg tablet QD
FTC/TDF placebo
Placebo to match FTC/TDF QD
ETV placebo
Placebo to match ETV QD
FTC/TDF
FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo QD
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD
TDF placebo
Placebo to match TDF QD
ETV placebo
Placebo to match ETV QD
Entecavir
ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo QD
Entecavir (ETV)
0.5-mg or 1-mg tablet QD
TDF placebo
Placebo to match TDF QD
FTC/TDF placebo
Placebo to match FTC/TDF QD
Interventions
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Tenofovir disoproxil fumarate (tenofovir DF; TDF)
300-mg tablet QD
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD
Entecavir (ETV)
0.5-mg or 1-mg tablet QD
TDF placebo
Placebo to match TDF QD
FTC/TDF placebo
Placebo to match FTC/TDF QD
ETV placebo
Placebo to match ETV QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
69 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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John Flaherty, PharmD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Pfleger Liver Institute
Los Angeles, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
University of Miami, Center for Liver Diseases
Miami, Florida, United States
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States
Henry Ford Hospital and Health System
Detroit, Michigan, United States
Mt. Sinai School of Medicine/ Mt. Sinai Medical Center
New York, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Metropolitan Research
Fairfax, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Heritage Medical Research Clinic
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
The Gordon & Leslie Diamond Centre
Vancouver, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Hopital Conception
Marseille, , France
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Berlin, , Germany
Universitat Heidelberg
Heidelberg, , Germany
Johannes Gutenberg-Universitat
Mainz, , Germany
General Hospital of Athens "Ippokratio"
Athens, , Greece
Universita de Padova
Padua, , Italy
Policlinico Universitario
Udine, , Italy
Wojewodzki Szpital Specjalistyczny im Dluskeigo
Bialystok, , Poland
Wojewodzki Szpital Obserwacy
Bydgoszcz, , Poland
Wojewodzki Szpital Zakazny
Warsaw, , Poland
National University Hospital Dept. of Gastroenterology & Hepatology
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
Hospital General Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona (HCPB)
Barcelona, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario y Politecnico la Fe
Valencia, , Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaoshiung Hsien, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
Chang-Gung Memorial Hospital
Taipei, , Taiwan
Marmara Universitesi School of Medicine
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, , Turkey (Türkiye)
Countries
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References
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Liaw YF, Sheen IS, Lee CM, Akarca US, Papatheodoridis GV, Suet-Hing Wong F, Chang TT, Horban A, Wang C, Kwan P, Buti M, Prieto M, Berg T, Kitrinos K, Peschell K, Mondou E, Frederick D, Rousseau F, Schiff ER. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology. 2011 Jan;53(1):62-72. doi: 10.1002/hep.23952. Epub 2010 Oct 27.
Other Identifiers
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GS-US-174-0108
Identifier Type: -
Identifier Source: org_study_id
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