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

Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: entecavir; Drug: Other anti-HBV medication

• Study Type: Observational
• Enrollment (Actual): 12522

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1181
    • Local Institution
  • Buenos Aires, Argentina, 1221
    • Local Institution
  • Neuquen, Argentina, 8300PMB
    • Local Institution
  • Buenos Aires
    • Ciudad De Buenos Aires, Buenos Aires, Argentina, 1155
      • Local Institution
    • El Palomar, Buenos Aires, Argentina, 1684
      • Local Institution
  • Jujuy
    • San Salvador De Jujuy, Jujuy, Argentina, Y4600ADE
      • Local Institution
  • Mendoza
    • Guaymallen, Mendoza, Argentina, 5519
      • Local Institution
  • Provincia de Salta
    • Salta, Provincia de Salta, Argentina, A4406CLA
      • Local Institution
• Brazil
  • Ribeirao Preto, Brazil, 14048-900
    • Local Institution
  • Rio De Janeiro, Brazil, 20270-004
    • Local Institution
  • Rio De Janeiro, Brazil, 20020
    • Local Institution
  • Sao Paulo, Brazil, 02128-000
    • Local Institution
  • AC
    • Rio Branco, AC, Brazil, 69914-220
      • Local Institution
  • Amazonas
    • Manaus, Amazonas, Brazil, 69040-000
      • Local Institution
  • Bahia
    • Salvador, Bahia, Brazil, 40110-060
      • Local Institution
    • Salvador, Bahia, Brazil, 40110-160
      • Local Institution
  • Goias
    • Goiania, Goias, Brazil, 74605-050
      • Local Institution
  • Mato Grosso
    • Cuiaba, Mato Grosso, Brazil, 78048-902
      • Local Institution
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Local Institution
    • Belo Horizonte, Minas Gerais, Brazil, 30110-934
      • Local Institution
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Local Institution
    • Ipatinga, Minas Gerais, Brazil, 35160-118
      • Local Institution
    • Juiz De Fora, Minas Gerais, Brazil, 36021-630
      • Local Institution
  • Para
    • Belem, Para, Brazil, 66035-080
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80240-280
      • Local Institution
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50100-130
      • Local Institution
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Local Institution
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Local Institution
    • Porto Alegres/rs, Rio Grande Do Sul, Brazil, 90020-090
      • Local Institution
  • Rio de Janeiro
    • Rio De Janeiro / Rj, Rio de Janeiro, Brazil, 21041-030
      • Local Institution
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Local Institution
  • Santa Catarina
    • Sao Jose, Santa Catarina, Brazil, 88103-400
      • Local Institution
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13060-904
      • Local Institution
    • Campinas, Sao Paulo, Brazil, 13083-888
      • Local Institution
    • Marilia, Sao Paulo, Brazil, 17519-000
      • Local Institution
    • Santo Andre - Sp, Sao Paulo, Brazil, 09060-870
      • Local Institution
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Local Institution
    • Sorocaba, Sao Paulo, Brazil, 18047-600
      • Local Institution
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Local Institution
    • Edmonton, Alberta, Canada, T6G 2E1
      • Local Institution
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1H2
      • Local Institution
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H2X 3J4
      • Local Institution
• China
  • Guangzhou, China, 510630
    • Local Institution
  • ShangHai, China, 200025
    • Local Institution
  • Anhui
    • Hefei, Anhui, China, 230022
      • Local Institution
  • Beijing
    • Beijing, Beijing, China, 100034
      • Local Institution
    • Beijing, Beijing, China, 100050
      • Local Institution
    • Beijing, Beijing, China, 100039
      • Local Institution
    • Beijing, Beijing, China, 100011
      • Local Institution
    • Beijing, Beijing, China, 100054
      • Local Institution
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Local Institution
    • Chongqing, Chongqing, China, 400010
      • Local Institution
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Local Institution
    • Guangzhou, Guangdong, China, 510060
      • Local Institution
    • Shenzhen, Guangdong, China, 518114
      • Local Institution
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Local Institution
  • Hainan
    • Haikou, Hainan, China, 570311
      • Local Institution
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Local Institution
    • Zhengzhou, Henan, China, 450003
      • Local Institution
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution
  • Hunan
    • Changsha, Hunan, China, 410008
      • Local Institution
    • Changsha, Hunan, China, 410011
      • Local Institution
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Local Institution
    • Nanjing, Jiangsu, China, 210029
      • Local Institution
    • Nanjing, Jiangsu, China, 210003
      • Local Institution
    • Suzhou, Jiangsu, China, 215006
      • Local Institution
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Local Institution
    • Shenyang, Liaoning, China, 110004
      • Local Institution
    • Shenyang, Liaoning, China, 110000
      • Local Institution
  • Shan1xi
    • Taiyuan, Shan1xi, China, 030001
      • Local Institution
  • Shan3xi
    • Xi'an, Shan3xi, China, 710038
      • Local Institution
    • Xi'an, Shan3xi, China, 710061
      • Local Institution
  • Shandong
    • Jinan, Shandong, China, 250021
      • Local Institution
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Local Institution
    • Shanghai, Shanghai, China, 200433
      • Local Institution
    • Shanghai, Shanghai, China
      • Local Institution
    • Shanghai, Shanghai, China, 200001
      • Local Institution
    • Shanghai, Shanghai, China, 200083
      • Local Institution
    • Shanghai, Shanghai, China, 200240
      • Local Institution
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution
  • Tianjin
    • Tianjin, Tianjin, China, 300170
      • Local Institution
    • Tianjin, Tianjin, China, 300192
      • Local Institution
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Local Institution
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution
    • Hangzhou, Zhejiang, China, 310014
      • Local Institution
    • Linhai, Zhejiang, China, 317000
      • Local Institution
    • Ningbo, Zhejiang, China, 315010
      • Local Institution
• Colombia
  • Bogota, Colombia
    • Local Institution
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Local Institution
• Czechia
  • Brno, Czechia, 625 00
    • Local Institution
  • Hradec Kralove, Czechia, 500 05
    • Local Institution
  • Ostrava, Czechia, 708 52
    • Local Institution
  • Prague 8, Czechia, 180 81
    • Local Institution
  • Usti Nad Labem, Czechia, 400 01
    • Local Institution
• France
  • Creteil, France, 94010
    • Local Institution
  • Grenoble Cedex 9, France, 38043
    • Local Institution
  • Lille, France, 59037
    • Local Institution
  • Limoges Cedex, France, 87042
    • Local Institution
  • Lyon, France, 69004
    • Local Institution
  • Paris, France, 75020
    • Local Institution
  • Paris Cedex, France, 75651
    • Local Institution
  • Paris Cedex 14, France, 75014
    • Local Institution
  • Vandoeuvre Cedex, France, 54511
    • Local Institution
• Germany
  • Berlin, Germany, 10117
    • Local Institution
  • Bonn, Germany, 53105
    • Local Institution
  • Dusseldorf, Germany, 40225
    • Local Institution
  • Hamburg, Germany, 20099
    • Local Institution
  • Leipzig, Germany, 04103
    • Local Institution
  • Tuebingen, Germany, 72076
    • Local Institution
  • Wurzburg, Germany, 97080
    • Local Institution
• Greece
  • Alexandroupolis, Greece, 68100
    • Local Institution
  • Athens, Greece, 11527
    • Local Institution
  • Athens, Greece, 11522
    • Local Institution
  • Kolonaki
    • Athens, Kolonaki, Greece, 10676
      • Local Institution
• India
  • Coimbatore, India, 641015
    • Local Institution
  • Hyderabad, India, 500058
    • Local Institution
  • Indore, India, 452014
    • Local Institution
  • Kolkata, India, 700054
    • Local Institution
  • Ludhiana, India, 141008
    • Local Institution
  • Mumbai, India, 400008
    • Local Institution
  • New Delhi, India, 110002
    • Local Institution
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500082
      • Local Institution
    • Hyderabad, Andhra Pradesh, India, 500034
      • Local Institution
    • Hyderabad, Andhra Pradesh, India, 500012
      • Local Institution
    • Hyderabad, Andhra Pradesh, India, 500068
      • Local Institution
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • Local Institution
  • Andhra Pradsh
    • Secunderabad, Andhra Pradsh, India, 500003
      • Local Institution
  • Gujarat
    • Ahemedabad, Gujarat, India, 380 006
      • Local Institution
    • Ahmedabad, Gujarat, India, 380006
      • Local Institution
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Local Institution
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • Local Institution
    • Bangalore, Karnataka, India, 560 054
      • Local Institution
    • Mangalore, Karnataka, India, 575002
      • Local Institution
  • Kerala
    • Kochi, Kerala, India, 682304
      • Local Institution
  • Madhya Pradesh
    • Bhopal, Madhya Pradesh, India, 462016
      • Local Institution
  • Maharashtra
    • Nagpur, Maharashtra, India, 440012
      • Local Institution
    • Nasik, Maharashtra, India, 422002
      • Local Institution
  • Punjab
    • Ludhiana, Punjab, India, 141001
      • Local Institution
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Local Institution
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625002
      • Local Institution
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600096
      • Local Institution
    • Madurai, Tamilnadu, India, 625107
      • Local Institution
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226014
      • Local Institution
• Italy
  • Bologna, Italy, 40138
    • Local Institution
  • Napoli, Italy, 80131
    • Local Institution
  • Rome, Italy, 00149
    • Local Institution
• Korea, Republic of
  • Bucheon, Korea, Republic of, 402-767
    • Local Institution
  • Busan, Korea, Republic of, 602-739
    • Local Institution
  • Busan, Korea, Republic of, 614-735
    • Local Institution
  • Busan, Korea, Republic of, 602-715
    • Local Institution
  • Busan, Korea, Republic of, 602-702
    • Local Institution
  • Chuncheon, Korea, Republic of, 200-704
    • Local Institution
  • Chung-ju, Korea, Republic of, 380-060
    • Local Institution
  • Dae-jeon, Korea, Republic of, 301-723
    • Local Institution
  • Daegu, Korea, Republic of, 700-712
    • Local Institution
  • Daegu, Korea, Republic of, 705-718
    • Local Institution
  • Daejeon City, Korea, Republic of, 302-721
    • Local Institution
  • Gangneung-si, Korea, Republic of, 210-711
    • Local Institution
  • Goyang, Korea, Republic of, 411-719
    • Local Institution
  • Gwangju, Korea, Republic of, 503-715
    • Local Institution
  • Gyeonggi-do, Korea, Republic of, 410-769
    • Local Institution
  • Gyeongju, Korea, Republic of, 780-350
    • Local Institution
  • Incheon, Korea, Republic of, 400-711
    • Local Institution
  • Incheon, Korea, Republic of, 405-760
    • Local Institution
  • Jinju, Korea, Republic of, 660-702
    • Local Institution
  • Koyang City, Korea, Republic of, 411-706
    • Local Institution
  • Seoul, Korea, Republic of, 135-710
    • Local Institution
  • Seoul, Korea, Republic of, 137-040
    • Local Institution
  • Seoul, Korea, Republic of, 138-736
    • Local Institution
  • Seoul, Korea, Republic of, 135-720
    • Local Institution
  • Seoul, Korea, Republic of, 140-743
    • Local Institution
  • Seoul, Korea, Republic of, 150-713
    • Local Institution
  • Seoul, Korea, Republic of, 152-703
    • Local Institution
  • Seoul, Korea, Republic of, 120-749
    • Local Institution
  • Seoul, Korea, Republic of, 130-702
    • Local Institution
  • Seoul, Korea, Republic of, 134-080
    • Local Institution
  • Seoul, Korea, Republic of, 150-071
    • Local Institution
  • Sungnam, Korea, Republic of, 463-712
    • Local Institution
  • Sungnam-si, Korea, Republic of, 463-774
    • Local Institution
  • Suwon, Korea, Republic of, 443-721
    • Local Institution
  • Suwon-si, Korea, Republic of, 442-723
    • Local Institution
  • Ulsan, Korea, Republic of, 682-714
    • Local Institution
  • Wonju, Korea, Republic of, 220-701
    • Local Institution
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 425-707
      • Local Institution
    • Uijeongbu-Si, Gyeonggi-do, Korea, Republic of, 480-717
      • Local Institution
• Mexico
  • Distrito Federal, Mexico, 14080
    • Local Institution
  • Durango, Mexico, 34208
    • Local Institution
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25000
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Local Institution
    • Guadalajara, Jalisco, Mexico, 44280
      • Local Institution
    • Zapopan, Jalisco, Mexico, 45200
      • Local Institution
    • Zapopan, Jalisco, Mexico, 45116
      • Local Institution
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62170
      • Local Institution
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • Local Institution
    • Monterrey, N.l., Nuevo Leon, Mexico, 64460
      • Local Institution
  • Sinaloa
    • Culiacan, Sin., Sinaloa, Mexico, 80230
      • Local Institution
  • Veracruz
    • Boca Del Rio, Veracruz, Mexico, 94298
      • Local Institution
• Philippines
  • Cebu City, Philippines, 6000
    • Local Institution
  • Davao City, Philippines, 8000
    • Local Institution
  • Ermita Manila, Philippines, 1000
    • Local Institution
  • Manila, Philippines, 1000
    • Local Institution
  • Manila, Philippines, 1003
    • Local Institution
  • Metro Manila, Philippines, 1500
    • Local Institution
  • Quezon City, Philippines, 1100
    • Local Institution
• Poland
  • Krakow, Poland, 31-501
    • Local Institution
  • Krakow, Poland, 31-202
    • Local Institution
  • Lodz, Poland, 91-347
    • Local Institution
  • Poznan, Poland, 61-285
    • Local Institution
  • Raciborz, Poland, 47-400
    • Local Institution
  • Szczecin, Poland, 71-455
    • Local Institution
  • Zawiercie, Poland, 42-400
    • Local Institution
• Portugal
  • Braga, Portugal, 4701-965
    • Local Institution
  • Coimbra, Portugal, 3050-075
    • Local Institution
  • Lisbon, Portugal, 1169-050
    • Local Institution
  • Porto, Portugal, 4200-319
    • Local Institution
• Romania
  • Bucharest, Romania, 022328
    • Local Institution
  • Bucharest, Romania, 020125
    • Local Institution
  • Bucharest, Romania, 050098
    • Local Institution
  • Bucharest, Romania, 021105
    • Local Institution
  • Bucharest, Romania, 030303
    • Local Institution
  • Constanta, Romania, 900591
    • Local Institution
  • Iasi, Romania, 700111
    • Local Institution
  • Timisoara, Romania, 300723
    • Local Institution
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Local Institution
  • Irkutsk, Russian Federation, 664047
    • Local Institution
  • Kirov, Russian Federation, 610000
    • Local Institution
  • Krasnoyarsk, Russian Federation, 660014
    • Local Institution
  • Lipetsk, Russian Federation, 398043
    • Local Institution
  • Moscow, Russian Federation, 125367
    • Local Institution
  • Moscow, Russian Federation, 119021
    • Local Institution
  • Moscow, Russian Federation, 119435
    • Local Institution
  • Nizhniy Novgord, Russian Federation, 603076
    • Local Institution
  • Nizhniy Novgorod, Russian Federation, 603022
    • Local Institution
  • Ryazan, Russian Federation, 390005
    • Local Institution
  • Samara, Russian Federation, 430063
    • Local Institution
  • Yakutsk, Russian Federation, 677005
    • Local Institution
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420097
      • Local Institution
• Singapore
  • Singapore, Singapore, 119228
    • Local Institution
• Spain
  • Granada, Spain, 18012
    • Local Institution
  • Madrid, Spain, 28006
    • Local Institution
  • Madrid, Spain, 28222
    • Local Institution
  • Oviedo, Spain, 33006
    • Local Institution
  • San Sebastian Guipuzcuoa, Spain, 20014
    • Local Institution
  • Sevilla, Spain, 41014
    • Local Institution
  • Valencia, Spain, 46010
    • Local Institution
• Taiwan
  • Kaohsiung, Taiwan, 833
    • Local Institution
  • Kaohsiung, Taiwan, 80756
    • Local Institution
  • Taichung, Taiwan, 404
    • Local Institution
  • Taichung, Taiwan, 40705
    • Local Institution
  • Taichung, Taiwan, 402
    • Local Institution
  • Tainan, Taiwan, 70428
    • Local Institution
  • Taipei, Taiwan, 100
    • Local Institution
  • Taipei, Taiwan, 112
    • Local Institution
  • Taipei, Taiwan, 10650
    • Local Institution
  • Young Kang City, Taiwan, 710
    • Local Institution
• Thailand
  • Bangkok, Thailand, 10400
    • Local Institution
  • Bangkok, Thailand, 10700
    • Local Institution
  • Bangkok, Thailand, 10330
    • Local Institution
  • Khon Kaen, Thailand, 40002
    • Local Institution
  • Pathumthani, Thailand, 12120
    • Local Institution
  • Songkhla
    • Hatyai, Songkhla, Thailand, 90110
      • Local Institution
• Turkey
  • Adana, Turkey, 01330
    • Local Institution
  • Ankara, Turkey, 06100
    • Local Institution
  • Eskisehir, Turkey, 26480
    • Local Institution
  • Izmir, Turkey, 35100
    • Local Institution
  • Izmir, Turkey, 35120
    • Local Institution
  • Kayseri, Turkey, 38039
    • Local Institution
  • Trabzon, Turkey, 61080
    • Local Institution
• United States
  • California
    • Coronado, California, United States, 92118
      • Scti Research Foundation
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Comprehensive Transplant Center
    • San Francisco, California, United States, 94118
      • Kaiser Permanente Medical Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030-1845
      • University of Connecticut Health Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Center for Liver Diseases
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Gastroenterology Associates
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Med Ctr
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5121
      • Indiana University
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
  • New York
    • Flushing, New York, United States, 11355
      • Medical Procare, PLLC
    • Flushing, New York, United States, 11355
      • Office Of Sing Chan Md
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10010
      • VA New York Harbor Healthcare System
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112-4481
      • Integris Baptist Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Medical College
    • Philadelphia, Pennsylvania, United States, 19106
      • Phgi Associates, Ltd
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Center for Liver Diseases
  • Texas
    • Dallas, Texas, United States, 7390-8887
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic hepatitis B patients receiving nucleoside therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adjudicated Overall Malignant Neoplasms	The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)	10 years
Number of Deaths	The number of deaths, as adjudicated by Events Adjudication Committee (EAC)	10 years
Number of Participants With Liver-related HBV Disease Progression	The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Non-HCC Malignant Neoplasm	The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)	10 years
Number of Participants With HCC Malignant Neoplasm	The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)	10 years
Number of Participants With Liver-related Death	The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)	10 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Chair: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Lim JK, Chang AY, Zaman A, Martin P, Fernandez-Rodriguez CM, Korkmaz M, Rossi S, Ford JM, Noonan T, Cooney E, Navarro V, Colombato L. Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B. J Clin Transl Hepatol. 2020 Dec 28;8(4):377-384. doi: 10.14218/JCTH.2020.00039. Epub 2020 Oct 10.
• Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG. Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries. Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.
• Hou JL, Jia JD, Wei L, Zhao W, Wang YM, Cheng M, Tang X, Tan DM, Ren H, Tang H, Cohen D, Llamoso C. Efficacy and safety of entecavir treatment in a heterogeneous CHB population from a 'real-world' clinical practice setting in China. J Viral Hepat. 2013 Nov;20(11):811-20. doi: 10.1111/jvh.12115.

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2006
• Primary Completion (Actual): October 26, 2016
• Study Completion (Actual): October 26, 2016

Study Registration Dates

• First Submitted: October 4, 2006
• First Submitted That Met QC Criteria: October 16, 2006
• First Posted (Estimate): October 17, 2006

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Hepatitis B Virus
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: AI463-080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No