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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00507507
Registration number
NCT00507507
Ethics application status
Date submitted
25/07/2007
Date registered
26/07/2007
Date last updated
17/07/2015
Titles & IDs
Public title
A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)
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Scientific title
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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Secondary ID [1]
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GS-US-203-0101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tenofovir DF
Treatment: Drugs - FTC
Treatment: Drugs - Placebo
Experimental: Tenofovir DF - Participants were randomized to receive tenofovir DF plus placebo to match FTC once daily.
Experimental: FTC+Tenofovir DF - Participants were randomized to receive FTC plus tenofovir DF once daily.
Treatment: Drugs: Tenofovir DF
Tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablet taken orally once daily
Treatment: Drugs: FTC
Emtricitabine (FTC) 200 mg capsule taken orally once daily
Treatment: Drugs: Placebo
Placebo to match FTC taken once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192
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Assessment method [1]
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The percentage of participants with HBV DNA \< 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.
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Timepoint [1]
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Week 192
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Secondary outcome [1]
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Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144
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Assessment method [1]
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The percentage of participants with HBV DNA \< 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.
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Timepoint [1]
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Weeks 48, 96, and 144
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Secondary outcome [2]
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Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192
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Assessment method [2]
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The percentage of participants with HBV DNA \< 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.
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Timepoint [2]
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Weeks 48, 96, 144, and 192
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Secondary outcome [3]
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Change From Baseline in HBV DNA at Week 48
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Assessment method [3]
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The change from baseline in HBV DNA at Week 48 was analyzed.
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Timepoint [3]
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Baseline to Week 48
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Secondary outcome [4]
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Change From Baseline in HBV DNA at Week 96
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Assessment method [4]
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The change from baseline in HBV DNA at Week 96 was analyzed.
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Timepoint [4]
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Baseline to Week 96
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Secondary outcome [5]
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Change From Baseline in HBV DNA at Week 144
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Assessment method [5]
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The change from baseline in HBV DNA at Week 144 was analyzed.
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Timepoint [5]
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Baseline to Week 144
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Secondary outcome [6]
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Change From Baseline in HBV DNA at Week 192
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Assessment method [6]
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The change from baseline in HBV DNA at Week 192 was analyzed.
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Timepoint [6]
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Baseline to Week 192
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Secondary outcome [7]
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Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192
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Assessment method [7]
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Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation.
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Timepoint [7]
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Weeks 48, 96, 144, and 192
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Secondary outcome [8]
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Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192
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Assessment method [8]
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The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
No statistical analysis is presented for Week 48 because no participants met the criteria at that time point.
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Timepoint [8]
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Weeks 48, 96, 144, and 192
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Secondary outcome [9]
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Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192
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Assessment method [9]
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The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.
No statistical analysis is presented for Week 48 because no participants met the criteria at that time point.
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Timepoint [9]
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Weeks 48, 96, 144, and 192
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Secondary outcome [10]
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Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192
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Assessment method [10]
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The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.
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Timepoint [10]
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Weeks 48, 96, 144, and 192
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Secondary outcome [11]
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Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192
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Assessment method [11]
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The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.
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Timepoint [11]
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Weeks 48, 96, 144, and 192
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Secondary outcome [12]
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Occurrence of HBV Resistance Mutations
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Assessment method [12]
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The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192).
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Timepoint [12]
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Baseline to Week 192
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Eligibility
Key inclusion criteria
* Chronic HBV infection, defined as positive serum HBsAg for at least 6 months or HBsAg positive > 3 months and positive for immunoglobulin G antibody against hepatitis B core antigen
* 18 through 69 years of age, inclusive
* Hepatitis B e antigen (HBeAg) positive
* HBV DNA = 10^8 copies/mL
* ALT = the upper limit of the normal range (ULN)
* Willing and able to provide written informed consent
* Negative serum beta-human chorionic gonadotropin (for females of childbearing potential only)
* Calculated creatinine clearance = 70 mL/min
* Hemoglobin = 10 g/dL
* Neutrophils = 1,500/mm^3
* No prior oral HBV therapy (eg, nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)
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Minimum age
18
Years
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Maximum age
69
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pregnant women, women who were breast feeding, or who believed they may have wished to become pregnant during the course of the study
* Males and females of reproductive potential unwilling to use an effective method of contraception during the study
* Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 x ULN, prothrombin time > 1.2 x ULN, platelets < 150,000/mm^3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, or variceal hemorrhage)
* Received interferon (pegylated or not) therapy within 6 months of the screening visit
* Alpha-fetoprotein > 50 ng/mL
* Evidence of hepatocellular carcinoma
* Coinfection with hepatitis C virus (by serology), HIV, or hepatitis D virus
* Significant renal, cardiovascular, pulmonary, or neurological disease
* Received solid organ or bone marrow transplantation
* Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
* Had proximal tubulopathy
* Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2012
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Sample size
Target
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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- Camperdown
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Recruitment hospital [2]
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- Westmead
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Recruitment hospital [3]
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- Heidelburg
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Recruitment hospital [4]
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- Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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3081 - Heidelburg
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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State/province [3]
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Michigan
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Tennessee
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Country [6]
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United States of America
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State/province [6]
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Washington
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Country [7]
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Canada
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State/province [7]
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Alberta
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Country [8]
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Canada
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State/province [8]
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British Columbia
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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France
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State/province [10]
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Lille
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Country [11]
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France
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State/province [11]
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Lyon
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Country [12]
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France
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State/province [12]
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Strasbourg
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Germany
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Berlin
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Germany
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Duesseldorf
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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State/province [20]
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Mainz
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Hong Kong
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State/province [21]
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Pokfulam
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Hong Kong
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Shatin
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Hong Kong
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State/province [23]
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Tai Po
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New Zealand
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State/province [24]
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Auckland
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New Zealand
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Hamilton
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Warszawa
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Singapore
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Singapore
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Taiwan
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Kaohsiung
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Taiwan
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Kaoshiung
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Taiwan
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State/province [32]
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Tainan
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Taiwan
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State/province [33]
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Taipei
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Country [34]
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United Kingdom
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State/province [34]
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London
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Country [35]
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United Kingdom
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State/province [35]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection. The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters. Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.
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Trial website
https://clinicaltrials.gov/study/NCT00507507
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00507507
Download to PDF