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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)
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
Secondary ID [1] 0 0
GS-US-203-0101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192
Timepoint [1] 0 0
Week 192
Secondary outcome [1] 0 0
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144
Timepoint [1] 0 0
Weeks 48, 96, and 144
Secondary outcome [2] 0 0
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192
Timepoint [2] 0 0
Weeks 48, 96, 144, and 192
Secondary outcome [3] 0 0
Change From Baseline in HBV DNA at Week 48
Timepoint [3] 0 0
Baseline to Week 48
Secondary outcome [4] 0 0
Change From Baseline in HBV DNA at Week 96
Timepoint [4] 0 0
Baseline to Week 96
Secondary outcome [5] 0 0
Change From Baseline in HBV DNA at Week 144
Timepoint [5] 0 0
Baseline to Week 144
Secondary outcome [6] 0 0
Change From Baseline in HBV DNA at Week 192
Timepoint [6] 0 0
Baseline to Week 192
Secondary outcome [7] 0 0
Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192
Timepoint [7] 0 0
Weeks 48, 96, 144, and 192
Secondary outcome [8] 0 0
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192
Timepoint [8] 0 0
Weeks 48, 96, 144, and 192
Secondary outcome [9] 0 0
Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192
Timepoint [9] 0 0
Weeks 48, 96, 144, and 192
Secondary outcome [10] 0 0
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192
Timepoint [10] 0 0
Weeks 48, 96, 144, and 192
Secondary outcome [11] 0 0
Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192
Timepoint [11] 0 0
Weeks 48, 96, 144, and 192
Secondary outcome [12] 0 0
Occurrence of HBV Resistance Mutations
Timepoint [12] 0 0
Baseline to Week 192

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)
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Westmead
Recruitment hospital [3] 0 0
- Heidelburg
Recruitment hospital [4] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3081 - Heidelburg
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
France
State/province [10] 0 0
Lille
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
France
State/province [12] 0 0
Strasbourg
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Duesseldorf
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Germany
State/province [18] 0 0
Heidelberg
Country [19] 0 0
Germany
State/province [19] 0 0
Herne
Country [20] 0 0
Germany
State/province [20] 0 0
Mainz
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Pokfulam
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Shatin
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Tai Po
Country [24] 0 0
New Zealand
State/province [24] 0 0
Auckland
Country [25] 0 0
New Zealand
State/province [25] 0 0
Hamilton
Country [26] 0 0
Poland
State/province [26] 0 0
Bydgoszcz
Country [27] 0 0
Poland
State/province [27] 0 0
Chorzow
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
Singapore
State/province [29] 0 0
Singapore
Country [30] 0 0
Taiwan
State/province [30] 0 0
Kaohsiung
Country [31] 0 0
Taiwan
State/province [31] 0 0
Kaoshiung
Country [32] 0 0
Taiwan
State/province [32] 0 0
Tainan
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei
Country [34] 0 0
United Kingdom
State/province [34] 0 0
London
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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