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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	16 October 2012
Main ID:	EUCTR2005-004096-37-ES
Date of registration:	03/03/2006
Prospective Registration:	Yes
Primary sponsor:	Gilead Sciences Incorporated
Public title:	A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus 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
Scientific title:	A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus 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
Date of first enrolment:	28/04/2006
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004096-37
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Germany	Greece	Ireland	Italy	Spain	United Kingdom

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
• Chronic HBV infection, defined as positive serum HBsAg for at least 6 months

• 18 through 69 years of age (inclusive)

• Serum HBV DNA = 10000 copies/mL (PCR method)

• Decompensated liver disease with all of the following:

- CPT score of 7-12 (inclusive)
- Serum ALT < 10 × ULN
- Hemoglobin = 7.5 g/dL
- Total WBC count = 1,500/mm3
- Platelet count = 30,000/mm3

• a-fetoprotein = 20 ng/mL and ultrasound or other imaging with no evidence of HCC, or a-fetoprotein of 21-50 ng/mL and CT/MRI with no evidence of HCC, within 3 months of screening

• Calculated creatinine clearance (CLcr) = 50 mL/min using the Cockcroft-Gault equation

• Negative HIV, HCV, and HDV serologies

• Less than 24 months of total prior adefovir dipivoxil exposure

• Willing and able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Pregnant women, women who are breast feeding 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. For males, condoms should be used and for females, a barrier contraception method should be used

• Prior use of tenofovir DF or entecavir

• History of variceal bleeding, hepatorenal syndrome, hepatic encephalopathy, or spontaneous bacterial peritonitis within 60 days of 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 agents

• Diagnosis of proximal tubulopathy

• Use of any investigational agent within 30 days prior to the screening visit

• Known hypersensitivity to tenofovir DF (or tenofovir), emtricitabine, entecavir, or formulation excipients of any of the study drug products

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B
MedDRA version: 8.1 Level: LLT Classification code 10008910

Intervention(s)

Trade Name: Viread
Product Name: Viread
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenofovir disoproxil fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Truvada
Product Name: Truvada
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenofovir disoproxil fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: emtricitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Baraclude
Product Name: Baraclude
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: entecavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: • To provide a preliminary assessment of the relative efficacy of tenofovir disoproxil fumarate, emtricitabine plus tenofovir disoproxil fumarate, and entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease

• To determine the probability of remaining free from HBV recurrence post-transplantation in each treatment group

• To determine the incidence and patterns of drug resistance mutations in HBV DNA polymerase in each treatment group

Main Objective: To evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate, emtricitabine plus tenofovir disoproxil fumarate, and entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease.

Primary end point(s): The co-primary endpoints to be evaluated among treatment groups in this exploratory study will include the following:

• Proportion of subjects experiencing tolerability failure. Tolerability failure is defined as permanent discontinuation of study drug due to a treatment-emergent AE. Any patient that temporarily discontinues study drug due to an AE but does not restart study drug will be considered a tolerability failure.

• Proportion of subjects with a confirmed increase in serum creatinine of = 0.5 mg/dL from baseline or a confirmed serum phosphorus < 2.0 mg/dL

Secondary Outcome(s)

Secondary ID(s)

2005-004096-37-IE

GS-US-174-0108

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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