Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/TDF, & Entecavir in the Treatment of Chronic HBV in Subjects w/Decompensated Liver Disease. - Full Text View

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00298363

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: tenofovir disoproxil fumarate Drug: emtricitabine / tenofovir disoproxil fumarate Drug: entecavir	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B Liver Diseases

Drug Information available for: Entecavir Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Hepatitis B Vaccines

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Safety (adverse events and laboratory tests, discontinuations due to adverse events) [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental tenofovir disoproxil fumarate 300 mg tablet, once-daily	Drug: tenofovir disoproxil fumarate 300 mg tablet, once-daily
2: Experimental emtricitabine / tenofovir disoproxil fumarate 200 mg tablet / 300 mg tablet, once daily (combination pill)	Drug: emtricitabine / tenofovir disoproxil fumarate 200 mg tablet / 300 mg tablet, once daily (combination pill)
3: Experimental entecavir 0.5 or 1 mg tablet, once daily	Drug: entecavir 0.5 or 1 mg tablet, once daily

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

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 </= 12.
- Serum ALT < 10 x ULN.
- Hemoglobin >/= 7.5 g/dL.
- Total WBC count >/= 1,500/mm3.
- Platelet count >/= 30,000/mm3.
Alpha-fetoprotein </= 20 ng/mL and ultrasound or other imaging with no evidence of 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298363

Show 55 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Chair:

Elsa Mondou, M.D.

Gilead Sciences

More Information

No publications provided

Responsible Party:	University of Miami ( Eugene Schiff )
Study ID Numbers:	GS-US-174-0108
Study First Received:	February 28, 2006
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00298363 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Hepatitis; Hepatitis B virus; Tenofovir

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Hepatitis, Viral, Human
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis

Virus Diseases
Entecavir
Digestive System Diseases
Anti-Retroviral Agents
Emtricitabine
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
Tenofovir
DNA Virus Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

ClinicalTrials.gov processed this record on February 08, 2010