Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
NCT ID: NCT00388674
Last Updated: 2018-07-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
12522 participants
OBSERVATIONAL
2006-12-18
2016-10-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Suboptimal Responders to Adefovir Switching to Entecavir
NCT00718887
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
NCT00096785
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
NCT00065507
Continue Entecavir Rollover From China
NCT00975091
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
NCT03577171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
entecavir
Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
B
Other anti-HBV medication
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
entecavir
Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
Other anti-HBV medication
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_CHAIR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scti Research Foundation
Coronado, California, United States
Cedars-Sinai Comprehensive Transplant Center
Los Angeles, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
University Of Connecticut Health Center
Farmington, Connecticut, United States
University Of Miami Center For Liver Diseases
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Rush University Med Ctr
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Medical Procare, Pllc
Flushing, New York, United States
Office Of Sing Chan Md
Flushing, New York, United States
Beth Israel Medical Center
New York, New York, United States
Va New York Harbor Healthcare System
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Phgi Associates, Ltd
Philadelphia, Pennsylvania, United States
Thomas Jefferson Medical College
Philadelphia, Pennsylvania, United States
Upmc Center For Liver Diseases
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution
El Palomar, Buenos Aires, Argentina
Local Institution
San Salvador de Jujuy, Jujuy Province, Argentina
Local Institution
Villa Nueva, Mendoza Province, Argentina
Local Institution
Salta, Salta Province, Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Neuquén, , Argentina
Local Institution
Rio Branco, Acre, Brazil
Local Institution
Manaus, Amazonas, Brazil
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution
Goiânia, Goiás, Brazil
Local Institution
Cuiabá, Mato Grosso, Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil
Local Institution
Ipatinga, Minas Gerais, Brazil
Local Institution
Juiz de Fora, Minas Gerais, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Belém, Pará, Brazil
Local Institution
Recife, Pernambuco, Brazil
Local Institution
Rio de Janeiro / Rj, Rio de Janeiro, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegres/rs, Rio Grande do Sul, Brazil
Local Institution
São José, Santa Catarina, Brazil
Local Institution
Campinas, São Paulo, Brazil
Local Institution
Campinas, São Paulo, Brazil
Local Institution
Marília, São Paulo, Brazil
Local Institution
Santo Andre - Sp, São Paulo, Brazil
Local Institution
São José do Rio Preto, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
Sorocaba, São Paulo, Brazil
Local Institution
Ribeirão Preto, , Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Hefei, Anhui, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Shenzhen, Guangdong, China
Local Institution
Guiyang, Guizhou, China
Local Institution
Haikou, Hainan, China
Local Institution
Zhengzhou, Henan, China
Local Institution
Zhengzhou, Henan, China
Local Institution
Wuhan, Hubei, China
Local Institution
Changsha, Hunan, China
Local Institution
Changsha, Hunan, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Suzhou, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Dalian, Liaoning, China
Local Institution
Shenyang, Liaoning, China
Local Institution
Shenyang, Liaoning, China
Local Institution
Taiyuan, Shan1xi, China
Local Institution
Xi'an, Shan3xi, China
Local Institution
Xi'an, Shan3xi, China
Local Institution
Jinan, Shandong, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Tianjin, Tianjin Municipality, China
Local Institution
Tianjin, Tianjin Municipality, China
Local Institution
Kunming, Yunnan, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Linhai, Zhejiang, China
Local Institution
Ningbo, Zhejiang, China
Local Institution
Guangzhou, , China
Local Institution
Shanghai, , China
Local Institution
Bogota, Cundinamarca, Colombia
Local Institution
Bogotá, , Colombia
Local Institution
Brno, , Czechia
Local Institution
Hradec Králové, , Czechia
Local Institution
Ostrava, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Ústí nad Labem, , Czechia
Local Institution
Créteil, , France
Local Institution
Grenoble, , France
Local Institution
Lille, , France
Local Institution
Limoges, , France
Local Institution
Lyon, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Berlin, , Germany
Local Institution
Bonn, , Germany
Local Institution
Düsseldorf, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Leipzig, , Germany
Local Institution
Tübingen, , Germany
Local Institution
Würzburg, , Germany
Local Institution
Athens, Kolonaki, Greece
Local Institution
Alexandroupoli, , Greece
Local Institution
Athens, , Greece
Local Institution
Athens, , Greece
Local Institution
Hyderabad, Andhra Pradesh, India
Local Institution
Hyderabad, Andhra Pradesh, India
Local Institution
Hyderabad, Andhra Pradesh, India
Local Institution
Hyderabad, Andhra Pradesh, India
Local Institution
Visakhapatnam, Andhra Pradesh, India
Local Institution
Secunderabad, Andhra Pradsh, India
Local Institution
Ahemedabad, Gujarat, India
Local Institution
Ahmedabad, Gujarat, India
Local Institution
Gurgaon, Haryana, India
Local Institution
Bangalore, Karnataka, India
Local Institution
Bangalore, Karnataka, India
Local Institution
Mangalore, Karnataka, India
Local Institution
Kochi, Kerala, India
Local Institution
Bhopal, Madhya Pradesh, India
Local Institution
Nagpur, Maharashtra, India
Local Institution
Nashik, Maharashtra, India
Local Institution
Ludhiana, Punjab, India
Local Institution
Jaipur, Rajasthan, India
Local Institution
Chennai, Tamil Nadu, India
Local Institution
Madurai, Tamil Nadu, India
Local Institution
Madurai, Tamil Nadu, India
Local Institution
Lucknow, Uttar Pradesh, India
Local Institution
Coimbatore, , India
Local Institution
Hyderabad, , India
Local Institution
Indore, , India
Local Institution
Kolkata, , India
Local Institution
Ludhiana, , India
Local Institution
Mumbai, , India
Local Institution
New Delhi, , India
Local Institution
Bologna, , Italy
Local Institution
Napoli, , Italy
Local Institution
Rome, , Italy
Local Institution
Saltillo, Coahuila, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Zapopan, Jalisco, Mexico
Local Institution
Zapopan, Jalisco, Mexico
Local Institution
Cuernavaca, Morelos, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Monterrey, N.l., Nuevo León, Mexico
Local Institution
Culiacan, Sin., Sinaloa, Mexico
Local Institution
Boca del Rio, Veracruz, Mexico
Local Institution
Distrito Federal, , Mexico
Local Institution
Durango, , Mexico
Local Institution
Cebu City, , Philippines
Local Institution
Davao City, , Philippines
Local Institution
Ermita Manila, , Philippines
Local Institution
Manila, , Philippines
Local Institution
Manila, , Philippines
Local Institution
Metro Manila, , Philippines
Local Institution
Quezon City, , Philippines
Local Institution
Krakow, , Poland
Local Institution
Krakow, , Poland
Local Institution
Lodz, , Poland
Local Institution
Poznan, , Poland
Local Institution
Racibórz, , Poland
Local Institution
Szczecin, , Poland
Local Institution
Zawiercie, , Poland
Local Institution
Braga, , Portugal
Local Institution
Coimbra, , Portugal
Local Institution
Lisbon, , Portugal
Local Institution
Porto, , Portugal
Local Institution
Bucharest, , Romania
Local Institution
Bucharest, , Romania
Local Institution
Bucharest, , Romania
Local Institution
Bucharest, , Romania
Local Institution
Bucharest, , Romania
Local Institution
Constanța, , Romania
Local Institution
Iași, , Romania
Local Institution
Timișoara, , Romania
Local Institution
Kazan', Tatarstan Republic, Russia
Local Institution
Arkhangelsk, , Russia
Local Institution
Irkutsk, , Russia
Local Institution
Kirov, , Russia
Local Institution
Krasnoyarsk, , Russia
Local Institution
Lipetsk, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Nizhniy Novgord, , Russia
Local Institution
Nizhny Novgorod, , Russia
Local Institution
Ryazan, , Russia
Local Institution
Samara, , Russia
Local Institution
Yakutsk, , Russia
Local Institution
Singapore, , Singapore
Local Institution
Ansan-si, Gyeonggi-do, South Korea
Local Institution
Uijeongbu-si, Gyeonggi-do, South Korea
Local Institution
Bucheon-si, , South Korea
Local Institution
Busan, , South Korea
Local Institution
Busan, , South Korea
Local Institution
Busan, , South Korea
Local Institution
Busan, , South Korea
Local Institution
Chuncheon, , South Korea
Local Institution
Chungju, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Daejeon, , South Korea
Local Institution
Daejeon, , South Korea
Local Institution
Gangneung-si, , South Korea
Local Institution
Goyang, , South Korea
Local Institution
Gwangju, , South Korea
Local Institution
Gyeonggi-do, , South Korea
Local Institution
Gyeongju, , South Korea
Local Institution
Incheon, , South Korea
Local Institution
Incheon, , South Korea
Local Institution
Jinju, , South Korea
Local Institution
Koyang City, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Sungnam-si, , South Korea
Local Institution
Sungnam, , South Korea
Local Institution
Suwon, , South Korea
Local Institution
Suwon, , South Korea
Local Institution
Ulsan, , South Korea
Local Institution
Wŏnju, , South Korea
Local Institution
Granada, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Oviedo, , Spain
Local Institution
San Sebastian Guipuzcuoa, , Spain
Local Institution
Seville, , Spain
Local Institution
Valencia, , Spain
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Tainan City, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Young Kang City, , Taiwan
Local Institution
Hat Yai, Changwat Songkhla, Thailand
Local Institution
Bangkok, , Thailand
Local Institution
Bangkok, , Thailand
Local Institution
Bangkok, , Thailand
Local Institution
Khon Kaen, , Thailand
Local Institution
Pathum Thani, , Thailand
Local Institution
Adana, , Turkey (Türkiye)
Local Institution
Ankara, , Turkey (Türkiye)
Local Institution
Eskişehir, , Turkey (Türkiye)
Local Institution
Izmir, , Turkey (Türkiye)
Local Institution
Izmir, , Turkey (Türkiye)
Local Institution
Kayseri, , Turkey (Türkiye)
Local Institution
Trabzon, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AI463-080
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.