Hepatitis B, ChronicPhase 3NCT00410072
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
A Phase 3 study testing Entecavir and Entecavir + Tenofovir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb at 68 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Entecavir and Entecavir + Tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 669 participants
- Where
- 68 sitesin 13 countries
- Study dates
- Apr 2007to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evidence of decompensated cirrhosis
- Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- Laboratory values out of protocol-specified range
Trial locations and contacts
68 sites in 13 countries.
68 sites in 13 countries
United States16 sites
University Of Michigan Health System
Ann Arbor, Michigan, 48109
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308
Digestive Healthcare Of Georgia
Atlanta, Georgia, 30309
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Sing Chan, Md
Flushing, New York, 11355
Maryland Digestive Disease Research, Llc
Laurel, Maryland, 20707
Sergio E. Rojter
Los Angeles, California, 90017
North Shore University
Manhasset, New York, 11030
University Of Miami
Miami, Florida, 33136
Yale University School Of Medicine
New Haven, Connecticut, 06510
Beth Israel Medical Center
New York, New York, 10003
Concorde Medical Group
New York, New York, 10016
Mount Sinai School Of Medicine
New York, New York, 10029
Tuan Nguyen, Md
San Diego, California, 92105
San Jose Gastroenterology
San Jose, California, 95128
Russia8 sites
Local Institution
Moscow, 105275
Local Institution
Moscow, 115446
Local Institution
Moscow, 117593
Local Institution
Saint Petersburg, 190103
Local Institution
Saint Petersburg, 191163
Local Institution
Saint Petersburg, 191167
Local Institution
Saint Petersburg, 194044
Local Institution
Smolensk, 214018
Canada6 sites
Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Toronto, Ontario, M3N 2V7
Local Institution
Toronto, Ontario, M5G 2N2
Local Institution
Toronto, Ontario, M5T 2S8
Local Institution
Vancouver, British Columbia, V5Z 1H2
Local Institution
Winnipeg, Manitoba, R3E 3P4
France6 sites
Local Institution
Grenoble, 38043
Local Institution
Marseille, 13285
Local Institution
Paris, 75013
Local Institution
Paris, 75014
Local Institution
Paris, 75571
Local Institution
Strasbourg, 67090
Australia5 sites
Local Institution
Clayton Vic, Victoria, 3168
Local Institution
Fitzroy, Victoria, 3065
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Prahan, Victoria, 3004
Local Institution
Westmead Nsw, New South Wales, 2145
Poland5 sites
Local Institution
Bialystok, 15-540
Local Institution
Chorzów, 41-500
Local Institution
Krakow, 31-531
Local Institution
Lublin, 20-081
Local Institution
Warsaw, 01-201
Argentina4 sites
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1121ABE
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1181ACH
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1282AEN
Local Institution
Rosario, Prov de Santa, S2000PBJ
India4 sites
Local Institution
Hyderabad, Andhra Pradesh, 500082
Local Institution
Lucknow, 226014
Local Institution
Ludhiana, 141001
Local Institution
Vellore, 632004
Italy4 sites
Local Institution
Antella Firenze, 50012
Local Institution
Brescia, 25123
Local Institution
Pisa, 56124
Local Institution
Roma, 00149
Turkey (Türkiye)4 sites
Local Institution
Bornova Izmir, 35100
Local Institution
Cebeci Ankara, 06620
Local Institution
Sihhiye Ankara, 06100
Local Institution
Trabzon, 61080
South Africa3 sites
Local Institution
Bellville, Western Cape, 7530
Local Institution
N1 City Goodwood, Western Cape, 7463
Local Institution
Pretoria, Gauteng, 0001
Brazil2 sites
Local Institution
Belo Horizonte, Minas Gerais, 30150
Local Institution
Porto Alegre Rs, Rio Grande do Sul, 90035
About this study
Official 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
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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Entecavir, Entecavir + Tenofovir
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Baraclude, BMS-200475
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Entecavir + TenofovirDrug
Also called Baraclude, BMS-200475
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
| Study group | Role | What they receive |
|---|---|---|
| TDF 0.5 mg | Experimental | TDF=tenofovir Receives: Drug: Entecavir |
| ETV 0.5 mg +TDF 300 mg | Experimental | ETV=entecavir; TDF=tenofovir Receives: Drug: Entecavir + Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Measured: At Week 96
Secondary outcomes (15)
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
HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Measured: At Weeks 48 and 96
Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96
LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Measured: At Weeks 48 and 96
Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96
LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Measured: At Weeks 48 and 96
Mean Log 10 HBV DNA at Weeks 48 and 96
HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load.
Measured: Baseline, Weeks 48 and 96
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96
ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Measured: At Weeks 48 and 96
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96
HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Measured: At Weeks 48 and 96
Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96
HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.
Measured: At Weeks 48 and 96
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96
HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Measured: At Weeks 48 and 96
Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection.
Measured: At Weeks 48 and 96
Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.
Measured: At Weeks 48 and 96
Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.
Measured: From enrollment through Week 100 + 24-week follow-up
Number of Participants With HBV Resistance Through Week 48
ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.
Measured: Week 48
Number of Participants With HBV Resistance at Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.
Measured: Week 96
Number of Participants With Virologic Breakthrough at Week 48
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir
Measured: Week 48
Number of Participants With Virologic Breakthrough at Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startApr 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410072
- Sponsor's protocol ID
- AI463-110
- Status last verified
- Mar 2013
- First submitted
- 11 Dec 2006
- Last updated
- 15 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 22643350
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00410072
- Acronym / sponsor ID
- AI463-110
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 Dec 2006 (estimated)
- Results
- Posted 3 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF 0.5 mg | Experimental | Drug: EntecavirTDF=tenofovir |
| ETV 0.5 mg +TDF 300 mg | Experimental | Drug: Entecavir + TenofovirETV=entecavir; TDF=tenofovir |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Evidence of decompensated cirrhosis
- Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- Laboratory values out of protocol-specified range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntecavirAlso: Baraclude, BMS-200475Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks | Drug | TDF 0.5 mg |
| Entecavir + TenofovirAlso: Baraclude, BMS-200475Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks | Drug | ETV 0.5 mg +TDF 300 mg |
Primary outcome
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
Time frame: At Week 96
HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
15 secondary outcomes
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
Time frame: At Weeks 48 and 96
Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Mean Log 10 HBV DNA at Weeks 48 and 96
Time frame: Baseline, Weeks 48 and 96
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
Time frame: At Weeks 48 and 96
Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
Time frame: From enrollment through Week 100 + 24-week follow-up
Number of Participants With HBV Resistance Through Week 48
Time frame: Week 48
Number of Participants With HBV Resistance at Week 96
Time frame: Week 96
Number of Participants With Virologic Breakthrough at Week 48
Time frame: Week 48
Number of Participants With Virologic Breakthrough at Week 96
Time frame: Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22643350Lok 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
68 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entecavir and Entecavir + Tenofovir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb at 68 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Russia, Canada, France, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 (time frame: At Week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00410072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.