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Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.

NCT00298363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2013-04-25

Study results available
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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 patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus.

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.

Conditions

Interventions

DRUG

Tenofovir disoproxil fumarate (tenofovir DF; TDF)

300-mg tablet QD

DRUG

Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD

DRUG

Entecavir (ETV)

0.5-mg or 1-mg tablet QD

DRUG

TDF placebo

Placebo to match TDF QD

DRUG

FTC/TDF placebo

Placebo to match FTC/TDF QD

DRUG

ETV placebo

Placebo to match ETV QD

Sponsors & Collaborators

Principal Investigators

  • John Flaherty, PharmD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • Singapore
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00298363 on ClinicalTrials.gov