Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00388674
First received: October 4, 2006
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.


Condition Intervention
Chronic Hepatitis B
Drug: entecavir
Drug: Other anti-HBV medication

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Rate of malignant neoplasms (overall and non-HCC, in each case including CIS but excluding non-melanoma skin cancer, and HCC) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Rate of liver-related events of HBV disease progression (including HCC and liver-related deaths) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Rate of mortality (all cause, liver-related) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

buccal


Estimated Enrollment: 12500
Study Start Date: December 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: entecavir
Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
Other Names:
  • Baraclude
  • BMS-200475
B Drug: Other anti-HBV medication
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic hepatitis B patients receiving nucleoside therapy

Criteria

Inclusion Criteria:

  • Chronic HBV infection
  • HBV nucleoside/tide-naive or -experienced
  • Patients who, in opinion of investigator, are appropriate for initiating or modifying their HBV therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either ETV or another standard of care HBV nucleoside/tide analogue
  • Age 16 and older or minimum age required in a given country

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year
  • Patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance
  • Coinfection with HIV
  • History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), but excluding non-melanoma skin cancers
  • Patients with chronic renal insufficiency, defined as a creatinine clearance < 50 ml/min who do not have either of the following means of dose reducing ETV:

    i. an approved country-specific ETV label which includes the extended interval ETV dose modification method and/or ii. an approved country specific label for the ETV oral solution AND access to the oral solution

  • History of dysplastic liver nodules
  • Known history of allergy to nucleoside/tide analogues
  • Prior or current treatment with entecavir
  • An investigator proposed study regimen which will include only interferon-alfa
  • An investigator proposed study regimen of combination (two or more) HBV nucleoside/tide analogues
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388674

  Hide Study Locations
Locations
United States, California
Scti Research Foundation
Coronado, California, United States, 92118
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
United States, Connecticut
University Of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
University Of Miami Center For Liver Diseases
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush University Med Ctr
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, New York
Medical Procare, Pllc
Flushing, New York, United States, 11355
Office Of Sing Chan Md
Flushing, New York, United States, 11355
Beth Israel Medical Center
New York, New York, United States, 10003
Va New York Harbor Healthcare System
New York, New York, United States, 10010
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Oklahoma
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Thomas Jefferson Medical College
Philadelphia, Pennsylvania, United States, 19107
Phgi Associates, Ltd
Philadelphia, Pennsylvania, United States, 19106
Upmc Center For Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
Argentina
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Ciudad De Buenos Aires, Buenos Aires, Argentina, 1155
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El Palomar, Buenos Aires, Argentina, 1684
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San Salvador De Jujuy, Jujuy, Argentina, Y4600ADE
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Guaymallen, Mendoza, Argentina, 5519
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Buenos Aires, Argentina, 1221
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Buenos Aires, Argentina, 1181
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Neuquen, Argentina, 8300PMB
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Salta, Argentina, A4406CLA
Brazil
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Rio Branco, Acre, Brazil, 69914
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Manaus, Amazonas, Brazil, 69040
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Salvador, Bahia, Brazil, 40110
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Salvador, Bahia, Brazil, 40110-160
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Goiania, Goias, Brazil, 74605
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Cuiaba, Mato Grosso, Brazil, 78048
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Belo Horizonte, Minas Gerais, Brazil, 30110
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Belo Horizonte, Minas Gerais, Brazil, 30130
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Belo Horizonte - Mg, Minas Gerais, Brazil, 30150
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Ipatinga, Minas Gerais, Brazil, 35160
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Juiz De Fora, Minas Gerais, Brazil, 36021
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Curitiba, Parana, Brazil, 80240
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Belem, Para, Brazil, 66035
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Recife, Pernambuco, Brazil, 50100
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Rio De Janeiro / Rj, Rio De Janeiro, Brazil, 21041
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035
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Porto Alegres/Rs, Rio Grande Do Sul, Brazil, 90020
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Sao Jose, Santa Catarina, Brazil, 88103
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Campinas, Sao Paulo, Brazil, 13059
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Campinas, Sao Paulo, Brazil, 13083
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Marilia, Sao Paulo, Brazil, 17519
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Ribeir?o Preto, Sao Paulo, Brazil, 14049
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Santo Andre - Sp, Sao Paulo, Brazil, 09060
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Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090
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Sao Paulo - Sp, Sao Paulo, Brazil, 05403
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Sorocaba, Sao Paulo, Brazil, 18047
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Rio De Janeiro, Brazil, 20020
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Rio De Janeiro, Brazil, 20270
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Sao Paulo, Brazil, 04044
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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Edmonton, Alberta, Canada, T6G 2E1
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Vancouver, British Columbia, Canada, V5Z 1H2
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Toronto, Ontario, Canada, M5G 2C4
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Montreal, Quebec, Canada, H2X 3J4
China, Anhui
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Hefei, Anhui, China, 230022
China, Beijing
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Beijing, Beijing, China, 100050
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Beijing, Beijing, China, 100011
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Beijing, Beijing, China, 100054
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Beijing, Beijing, China, 100039
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Beijing, Beijing, China, 100034
China, Chongqing
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Chongqing, Chongqing, China, 400038
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Chongqing, Chongqing, China, 400010
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Shenzhen, Chongqing, China, 518020
China, Guangdong
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Guangzhou, Guangdong, China, 510630
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Guangzhou, Guangdong, China, 510060
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Guangzhou, Guangdong, China, 510515
China, Guizhou
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Guiyang, Guizhou, China, 550004
China, Hainan
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Haikou, Hainan, China, 570311
China, Henan
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Zhengzhou, Henan, China, 450003
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Zhengzhou, Henan, China, 450052
China, Hubei
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Wuhan, Hubei, China, 430022
China, Hunan
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Changsha, Hunan, China, 410011
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Changsha, Hunan, China, 410008
China, Jiangsu
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Nanjing, Jiangsu, China, 210003
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Nanjing, Jiangsu, China, 210002
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Nanjing, Jiangsu, China, 210029
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Suzhou, Jiangsu, China, 215006
China, Jilin
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Changchun, Jilin, China, 130021
China, Liaoning
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Dalian, Liaoning, China, 116001
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Shenyang, Liaoning, China, 110000
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Shenyang, Liaoning, China, 110004
China, Shandong
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Jinan, Shandong, China, 250021
China, Shanghai
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Shanghai, Shanghai, China, 200235
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Shanghai, Shanghai, China, 200040
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Shanghai, Shanghai, China, 200433
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Shanghai, Shanghai, China, 200083
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Shanghai, Shanghai, China, 200240
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Shanghai, Shanghai, China, 200025
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Shanghai, Shanghai, China, 200032
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Shanghai, Shanghai, China, 200001
China, Sichuan
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Chengdu, Sichuan, China, 610041
China, Tianjin
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Tianjin, Tianjin, China, 300170
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Tianjin, Tianjin, China, 300192
China, Yunnan
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Kunming, Yunnan, China, 650032
China, Zhejiang
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Hangzhou, Zhejiang, China, 310014
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Hangzhou, Zhejiang, China, 310003
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Linhai, Zhejiang, China, 317000
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Ningbo, Zhejiang, China, 315010
China
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Taiyuan, China, 030001
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Xi'An, China, 710061
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Xi'An, China, 710038
Colombia
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Bogota, Cundinamarca, Colombia
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Bogota, Colombia
Czech Republic
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Brno, Czech Republic, 625 00
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Hradec Kralove, Czech Republic, 500 05
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Ostrava, Czech Republic, 708 52
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Prague 8, Czech Republic, 180 81
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Usti Nad Labem, Czech Republic, 400 01
France
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Lillie, Cedex, France, 59037
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Creteil, France, 94010
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Grenoble Cedex 9, France, 38043
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Limoges Cedex, France, 87042
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Lyon Cedex 02, France, 69288
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Paris, France, 75020
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Paris Cedex, France, 75651
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Paris Cedex 14, France, 75014
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Vandoeuvre Cedex, France, 54511
Germany
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Berlin, Germany, 10117
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Bonn, Germany, 53105
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Dusseldorf, Germany, 40225
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Hamburg, Germany, 20099
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Leipzig, Germany, 04103
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Tuebingen, Germany, 72076
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Wurzburg, Germany, 97080
Greece
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Alexandroupolis, Greece, 68100
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Athens, Greece, 11522
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Athens, Greece, 11527
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Athens, Greece, 10676
India
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Hyderabad, Andhra Pradesh, India, 500068
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Hyderabad, Andhra Pradesh, India, 500034
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Hyderabad, Andhra Pradesh, India, 500082
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Hyderabad, Andhra Pradesh, India, 500012
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Visakhapatnam, Andhra Pradesh, India, 530002
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Secunderabad, Andhra Pradsh, India, 500003
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Ahemedabad, Gujarat, India, 380 006
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Ahmedabad, Gujarat, India, 380006
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Bangalore, Karnataka, India, 560 054
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Bangalore, Karnataka, India, 560034
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Mangalore, Karnataka, India, 575002
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Kochi, Kerala, India, 682304
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Bhopal, Madhya Pradesh, India, 462016
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Nagpur, Maharashtra, India, 440012
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Nasik, Maharashtra, India, 422002
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Ludhiana, Punjab, India, 141001
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Jaipur, Rajasthan, India, 302017
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Madurai, Tamil Nadu, India, 625002
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Chennai, Tamilnadu, India, 600096
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Madurai, Tamilnadu, India, 625107
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Coimbatore, India, 641015
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Hyderabad, India, 500058
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Indore, India, 452014
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Kolkata, India, 700054
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Lucknow, India, 226014
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Ludhiana, India, 141008
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Mumbai, India, 400008
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New Delhi, India, 110060
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New Delhi, India, 110002
Italy
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Bologna, Italy, 40138
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Napoli, Italy, 80131
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Rome, Italy, 00149
Korea, Republic of
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Ansan-Si, Gyeonggi-Do, Korea, Republic of, 425-707
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Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
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Uijeongbu, Gyeonggi-Do, Korea, Republic of, 480-717
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Bucheon, Korea, Republic of, 402-767
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Busan, Korea, Republic of, 602-715
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Busan, Korea, Republic of, 602-739
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Busan, Korea, Republic of, 614-735
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Busan, Korea, Republic of, 602-702
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Chuncheon, Korea, Republic of, 200-704
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Chung-Ju, Korea, Republic of, 380-060
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Dae-Jeon, Korea, Republic of, 301-723
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Daegu, Korea, Republic of, 700-712
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Daegu, Korea, Republic of, 705-718
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Daejeon City, Korea, Republic of, 302-721
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Gangneung-Si, Korea, Republic of, 210-711
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Goyang, Korea, Republic of, 411-719
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Gwangju, Korea, Republic of, 503-715
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Gyeongju, Korea, Republic of, 780-350
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Incheon, Korea, Republic of, 405-760
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Incheon, Korea, Republic of, 400-711
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Jinju, Korea, Republic of, 660-702
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Koyang City, Korea, Republic of, 411-706
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Seoul, Korea, Republic of, 152-703
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Seoul, Korea, Republic of, 120-749
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 130-702
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Seoul, Korea, Republic of, 150-071
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 137-040
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Seoul, Korea, Republic of, 140-890
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 150-713
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Seoul, Korea, Republic of, 134-080
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Sungnam, Korea, Republic of, 463-712
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Sungnam-Si, Korea, Republic of, 463-774
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Suwon, Korea, Republic of, 443-721
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Suwon-Si, Korea, Republic of, 442-723
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Ulsan, Korea, Republic of, 682-714
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Wonju, Korea, Republic of, 220-701
Mexico
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Saltillo, Coahuila, Mexico, 25000
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Guadalajara, Jalisco, Mexico, 44160
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Guadalajara, Jalisco, Mexico, 44280
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Zapopan, Jalisco, Mexico, 45116
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Zapopan, Jalisco, Mexico, 45200
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Cuernavaca, Morelos, Mexico, 62260
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Monterrey, Nuevo Leon, Mexico, 64710
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Monterrey, N.L., Nuevo Leon, Mexico, 64460
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Culiacan, Sin., Sinaloa, Mexico, 80230
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Boca Del Rio, Veracruz, Mexico, 94298
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Distrito Federal, Mexico, 14080
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Durango, Mexico, 34208
Philippines
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Cebu City, Philippines, 6000
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Davao City, Philippines, 8000
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Ermita Manila, Philippines, 1000
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Manila, Philippines, 1003
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Manila, Philippines, 1000
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Metro Manila, Philippines, 1500
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Quezon City, Philippines, 1100
Poland
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Krakow, Poland, 31-501
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Krakow, Poland, 31-202
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Lodz, Poland, 91-347
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Poznan, Poland, 61-285
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Raciborz, Poland, 47-400
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Szczecin, Poland, 71-455
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Zawiercie, Poland, 42-400
Portugal
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Braga, Portugal, 4701-965
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Coimbra, Portugal, 3050-075
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Lisbon, Portugal, 1169-050
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Porto, Portugal, 4200
Romania
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Bucharest, Romania, 022328
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Bucharest, Romania, 030303
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Bucharest, Romania, 020125
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Bucharest, Romania, 050098
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Bucharest, Romania, 021105
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Constanta, Romania, 900591
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Iasi, Romania, 700111
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Timisoara, Romania, 300723
Russian Federation
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Kazan, Tatarstan, Russian Federation, 420097
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Arkhangelsk, Russian Federation, 163045
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Irkutsk, Russian Federation, 664047
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Kirov, Russian Federation, 610000
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Krasnoyarsk, Russian Federation, 660014
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Lipetsk, Russian Federation, 398043
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Moscow, Russian Federation, 119021
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Moscow, Russian Federation, 125367
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Moscow, Russian Federation, 119435
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Nizhniy Novgorod, Russian Federation, 603022
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Ryazan, Russian Federation, 390005
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Samara, Russian Federation, 443011
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Yakutsk, Russian Federation, 677005
Singapore
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Singapore, Singapore, 119228
Spain
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Granada, Spain, 18012
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Madrid, Spain, 28222
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Madrid, Spain, 28006
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Oviedo, Spain, 33006
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San Sebastian Guipuzcuoa, Spain, 20014
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Sevilla, Spain, 41014
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Valencia, Spain, 46010
Taiwan
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Kaohsiung, Taiwan, 80756
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Kaohsiung, Taiwan, 833
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 402
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Taichung, Taiwan, 404
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Tainan, Taiwan, 70428
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Taipei, Taiwan, 100
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Taipei, Taiwan, 112
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Taipei, Taiwan, 10650
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Young Kang City, Taiwan, 710
Thailand
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Hatyai, Songkhla, Thailand, 90110
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10330
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Khon Kaen, Thailand, 40002
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Pathumthani, Thailand, 12120
Turkey
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Adana, Turkey, 01330
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Ankara, Turkey, 06100
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Eskisehir, Turkey, 26480
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Izmir, Turkey, 35100
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Izmir, Turkey, 35310
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Kayseri, Turkey, 38039
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Trabzon, Turkey, 61080
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Chair: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00388674     History of Changes
Other Study ID Numbers: AI463-080
Study First Received: October 4, 2006
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Chronic Hepatitis B Virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014