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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
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
Trial website
https://clinicaltrials.gov/study/NCT00410072
Trial related presentations / publications
Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, Sievert W, Wong D, Lovegren M, Cohen D, Llamoso C. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology. 2012 Sep;143(3):619-628.e1. doi: 10.1053/j.gastro.2012.05.037. Epub 2012 May 27.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00410072