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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. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2006-004714-40-GB |
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Date of registration:
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31/07/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized, Double Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B
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Scientific title:
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A Randomized, Double Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B |
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Date of first enrolment:
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19/09/2007 |
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Target sample size:
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130 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004714-40 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Germany
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
•Chronic HBV infection, defined as positive serum HBsAg for at least 6 months or HBsAg positive > 3 months and negative for IgM anti-HBc
•18 through 69 years of age, inclusive
•HBeAg positive
•HBV DNA = 108 copies/mL
•ALT = ULN
•Willing and able to provide written informed consent
•Negative serum ß HCG (for females of childbearing potential only)
•Calculated creatinine clearance = 70 mL/min by the following formula:
(140-age in years) (body weight [kg])
(72) (serum creatinine [mg/dl])
[Note: multiply estimated rate by 0.85 for women]
•Hemoglobin = 10 g/dL
•Neutrophils = 1,500 /mm3
•No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection).
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 not willing 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 in combination with one other form of contraception.
•Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 x ULN, PT > 1.2 x ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage).
•Received interferon (pegylated or not) therapy within 6 months of the screening visit
•a fetoprotein > 50 ng/mL
•Evidence of hepatocellular carcinoma (HCC)
•Co infection with HCV (by serology), HIV, or HDV.
•Significant renal, cardiovascular, pulmonary, or neurological disease.
•Received solid organ or bone marrow transplantation.
•Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
•Has proximal tubulopathy.
•Known hypersensitivity to the study drugs, the metabolites or formulation excipients.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis B
MedDRA version: 9.1
Level: LLT
Classification code 10008910
Term: Chronic hepatitis B
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Intervention(s)
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Trade 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-
Trade Name: Emtriva
Pharmaceutical Form: Capsule*
INN or Proposed INN: emtricitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): •The primary endpoint is HBV DNA < 400 copies/mL. Using group sequential testing for the primary efficacy analysis, the primary efficacy endpoint will be evaluated after the last subject reaches Week 48 and every 48 weeks thereafter.
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Secondary Objective: •To evaluate the safety and tolerability of tenofovir DF versus tenofovir DF plus emtricitabine combination therapy
•To evaluate the biochemical and serological response to tenofovir DF monotherapy versus tenofovir DF plus emtricitabine combination therapy
•To compare the incidence of drug resistant mutations between treatment arms
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Main Objective: •To compare the antiviral efficacy against hepatitis B virus (HBV) of tenofovir DF monotherapy versus tenofovir DF plus emtricitabine combination therapy
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Secondary ID(s)
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GS-US-203-0101
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2006-004714-40-FR
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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