Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/TDF, & Entecavir in the Treatment of Chronic HBV in Subjects w/Decompensated Liver Disease.
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: tenofovir disoproxil fumarate (Drug); emtricitabine / tenofovir disoproxil fumarate (Drug); entecavir (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
Elsa Mondou, M.D., Study Chair, Affiliation: Gilead Sciences
Summary
The study is designed to evaluate and compare the safety and tolerability of tenofovir
disoproxil fumarate (DF), emtricitabine/tenofovir DF, and entecavir in the treatment of
hepatitis B patients with decompensated liver disease.
Clinical Details
Official title: Phase 2, Double-Blind, Multi-Center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine/Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects With Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantation.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety (adverse events and laboratory tests, discontinuations due to adverse events)
Detailed description:
Safety will be assessed by evaluating adverse events, laboratory abnormalities and the
development of drug-resistant mutations. Efficacy will be evaluated for reductions in
Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in
HBV DNA, changes in liver enzymes, and the generation of antibody to virus.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
A patient must 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 a past history of CPT score >/= 7 and any CPT at
screen - Serum ALT < 10 x ULN.
- Hemoglobin >/= 7. 5 g/dL.
- Total WBC count >/= 1,500/mm3.
- Platelet count >/= 30,000/mm3.
- Alpha-fetoprotein
HCC, or alpha-fetoprotein of 21-50 ng/mL and CT/MRI with no evidence of HCC, within 6
months of screening.
- Calculated creatinine clearance >/= 50 mL/min.
- Negative HIV, HCV and HDV serologies.
- Less than 24 months of total prior adefovir dipivoxil exposure.
Exclusion Criteria:
A patient who meets any of the following exclusion criteria cannot be enrolled in the
study:
- Pregnant women, women who are breastfeeding or who believe they may wish to become
pregnant during the course of the study.
- Males and females of reproductive potential who are unwilling to use an "effective"
method of contraception during the study.
- Prior use of tenofovir DF or entecavir.
- History of variceal bleeding, hepatorenal syndrome, Grade 3 or Grade 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 (e. g., corticosteroids, IL-2, etc) or
investigational drugs.
- Diagnosis of proximal tubulopathy.
- Use of investigational agent within 30 days prior to screening.
Locations and Contacts
Clichy 92210, France
Lyon 69288, France
Marseille F13385, France
Villejuif 94800, France
Berlin 13353, Germany
Hamburg 20251, Germany
Hannover 30623, Germany
Heidelberg 69120, Germany
Mainz 55131, Germany
Frankfurt 60590, Germany
Thessaloniki 570 10, Greece
Thessaloniki 546 42, Greece
Athens 115 27, Greece
Dublin, Ireland
Padova 35123, Italy
Padova 35128, Italy
Torino 10134, Italy
Udine 33100, Italy
Bialystok 15-540, Poland
Bydgoszcz 85-030, Poland
Warsaw 01-201, Poland
Singapore 119074, Singapore
Singapore 169608, Singapore
Singapore 529889, Singapore
Singapore 308433, Singapore
Barcelona 08035, Spain
Barcelona 08907, Spain
Barcelona 08036, Spain
Madrid 28007, Spain
Valencia 46009, Spain
Taipei City 114, Taiwan
Taoyuan Hsien 333, Taiwan
Tainan 704, Taiwan
Kaoshiung Hsien 833, Taiwan
Taipei, Taiwan
Ankara, Turkey
Izmir, Turkey
Istanbul, Turkey
Bursa 16059, Turkey
Besevler -Ankara 06510, Turkey
Calgary, Alberta T2N4N1, Canada
Vancouver, British Columbia V5Z1H2, Canada
Vancouver, British Columbia V5Z3P1, Canada
Los Angeles, California 90095, United States
San Francisco, California 94115, United States
San Diego, California 92103, United States
Jacksonville, Florida 32216, United States
Miami, Florida 33136, United States
Detroit, Michigan 48202, United States
New York, New York 10032, United States
New York, New York 10029, United States
Toronto, Ontario M5G 2C4, Canada
Houston, Texas 77030, United States
Fairfax, Virginia 22031, United States
Seattle, Washington 98104, United States
Additional Information
Starting date: March 2006
Ending date: December 2010
Last updated: January 4, 2008
|
