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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00410072




Registration number
NCT00410072
Ethics application status
Date submitted
11/12/2006
Date registered
12/12/2006
Date last updated
15/03/2013

Titles & IDs
Public title
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
Scientific title
A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study
Secondary ID [1] 0 0
AI463-110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 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 - Entecavir
Treatment: Drugs - Entecavir + Tenofovir

Experimental: TDF 0.5 mg - TDF=tenofovir

Experimental: ETV 0.5 mg +TDF 300 mg - ETV=entecavir; TDF=tenofovir


Treatment: Drugs: Entecavir
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks

Treatment: Drugs: Entecavir + Tenofovir
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Timepoint [1] 0 0
At Week 96
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status
Timepoint [1] 0 0
At Weeks 48 and 96
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96
Timepoint [2] 0 0
At Weeks 48 and 96
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96
Timepoint [3] 0 0
At Weeks 48 and 96
Secondary outcome [4] 0 0
Mean Log 10 HBV DNA at Weeks 48 and 96
Timepoint [4] 0 0
Baseline, Weeks 48 and 96
Secondary outcome [5] 0 0
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96
Timepoint [5] 0 0
At Weeks 48 and 96
Secondary outcome [6] 0 0
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96
Timepoint [6] 0 0
At Weeks 48 and 96
Secondary outcome [7] 0 0
Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96
Timepoint [7] 0 0
At Weeks 48 and 96
Secondary outcome [8] 0 0
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96
Timepoint [8] 0 0
At Weeks 48 and 96
Secondary outcome [9] 0 0
Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96
Timepoint [9] 0 0
At Weeks 48 and 96
Secondary outcome [10] 0 0
Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
Timepoint [10] 0 0
At Weeks 48 and 96
Secondary outcome [11] 0 0
Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
Timepoint [11] 0 0
From enrollment through Week 100 + 24-week follow-up
Secondary outcome [12] 0 0
Number of Participants With HBV Resistance Through Week 48
Timepoint [12] 0 0
Week 48
Secondary outcome [13] 0 0
Number of Participants With HBV Resistance at Week 96
Timepoint [13] 0 0
Week 96
Secondary outcome [14] 0 0
Number of Participants With Virologic Breakthrough at Week 48
Timepoint [14] 0 0
Week 48
Secondary outcome [15] 0 0
Number of Participants With Virologic Breakthrough at Week 96
Timepoint [15] 0 0
Week 96

Eligibility
Key inclusion criteria
* Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HbeAg]-positive or negative) disease
* Nucleoside- and nucleotide-naive
* Males or females =16 years of age (or minimum age of consent in a given country)
* Compensated liver function
* HBV DNA >1.72*10*5*IU/mL (approximately 10*6*copies/mL) for HbeAg-positive participants
* HBV DNA >1.72*10*4*IU/mL (approximately 10*5*copies/mL) for Hbe-Ag-negative participants
* Alanine aminotransferase level =*upper limit of normal (ULN) and =10*ULN
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of decompensated cirrhosis
* Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* Laboratory values out of protocol-specified range

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
669
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - Westmead Nsw
Recruitment hospital [2] 0 0
Local Institution - Clayton Vic
Recruitment hospital [3] 0 0
Local Institution - Fitzroy
Recruitment hospital [4] 0 0
Local Institution - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - Prahan
Recruitment postcode(s) [1] 0 0
2145 - Westmead Nsw
Recruitment postcode(s) [2] 0 0
3168 - Clayton Vic
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Prahan
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Prov De Santa
Country [11] 0 0
Brazil
State/province [11] 0 0
Minas Gerais
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio Grande Do Sul
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Manitoba
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
France
State/province [17] 0 0
Grenoble Cedex 09
Country [18] 0 0
France
State/province [18] 0 0
Marseille Cedex 08
Country [19] 0 0
France
State/province [19] 0 0
Paris Cedex 12
Country [20] 0 0
France
State/province [20] 0 0
Paris Cedex 13
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Strasbourg
Country [23] 0 0
India
State/province [23] 0 0
Andhra Pradesh
Country [24] 0 0
India
State/province [24] 0 0
Lucknow
Country [25] 0 0
India
State/province [25] 0 0
Ludhiana
Country [26] 0 0
India
State/province [26] 0 0
Vellore
Country [27] 0 0
Italy
State/province [27] 0 0
Antella Firenze
Country [28] 0 0
Italy
State/province [28] 0 0
Brescia
Country [29] 0 0
Italy
State/province [29] 0 0
Pisa
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Mexico
State/province [31] 0 0
Durango
Country [32] 0 0
Poland
State/province [32] 0 0
Bialystok
Country [33] 0 0
Poland
State/province [33] 0 0
Chorzow
Country [34] 0 0
Poland
State/province [34] 0 0
Krakow
Country [35] 0 0
Poland
State/province [35] 0 0
Lublin
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Smolensk
Country [39] 0 0
Russian Federation
State/province [39] 0 0
St. Petersburg
Country [40] 0 0
South Africa
State/province [40] 0 0
Gauteng
Country [41] 0 0
South Africa
State/province [41] 0 0
Western Cape
Country [42] 0 0
Turkey
State/province [42] 0 0
Bornova Izmir
Country [43] 0 0
Turkey
State/province [43] 0 0
Cebeci Ankara
Country [44] 0 0
Turkey
State/province [44] 0 0
Sihhiye Ankara
Country [45] 0 0
Turkey
State/province [45] 0 0
Trabzon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/NCT00410072