AzTrials
AzTrials

Chronic Hepatitis BNCT00388674

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

An observational study of Chronic Hepatitis B, run by Bristol-Myers Squibb at 290 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Chronic Hepatitis B
What is being tested?
entecavir and Other anti-HBV medication
Type of treatment
Pill or oral medicine
How many people
12,522 participants
Where
290 sitesin 24 countries
Study dates
18 Dec 2006to 26 Oct 2016
Phase
Observational
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

Study population: Chronic hepatitis B patients receiving nucleoside therapy

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 12Show fewer
  • 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

Trial locations and contacts

290 sites in 24 countries.

290 sites in 24 countries

China46 sites

  • Local Institution

    Beijing, Beijing Municipality, 100011

  • Local Institution

    Beijing, Beijing Municipality, 100034

  • Local Institution

    Beijing, Beijing Municipality, 100039

  • Local Institution

    Beijing, Beijing Municipality, 100050

  • Local Institution

    Beijing, Beijing Municipality, 100054

  • Local Institution

    Changchun, Jilin, 130021

  • Local Institution

    Changsha, Hunan, 410008

  • Local Institution

    Changsha, Hunan, 410011

  • Local Institution

    Chengdu, Sichuan, 610041

  • Local Institution

    Chongqing, Chongqing Municipality, 400010

  • Local Institution

    Chongqing, Chongqing Municipality, 400038

  • Local Institution

    Dalian, Liaoning, 116001

  • Local Institution

    Guangzhou, Guangdong, 510060

  • Local Institution

    Guangzhou, Guangdong, 510515

  • Local Institution

    Guangzhou, 510630

  • Local Institution

    Guiyang, Guizhou, 550004

  • Local Institution

    Haikou, Hainan, 570311

  • Local Institution

    Hangzhou, Zhejiang, 310003

  • Local Institution

    Hangzhou, Zhejiang, 310014

  • Local Institution

    Hefei, Anhui, 230022

  • Local Institution

    Jinan, Shandong, 250021

  • Local Institution

    Kunming, Yunnan, 650032

  • Local Institution

    Linhai, Zhejiang, 317000

  • Local Institution

    Nanjing, Jiangsu, 210002

  • Local Institution

    Nanjing, Jiangsu, 210003

  • Local Institution

    Nanjing, Jiangsu, 210029

  • Local Institution

    Ningbo, Zhejiang, 315010

  • Local Institution

    Shanghai, Shanghai Municipality, 200001

  • Local Institution

    Shanghai, Shanghai Municipality, 200040

  • Local Institution

    Shanghai, Shanghai Municipality, 200083

  • Local Institution

    Shanghai, Shanghai Municipality, 200240

  • Local Institution

    Shanghai, Shanghai Municipality, 200433

  • Local Institution

    Shanghai, Shanghai Municipality

  • Local Institution

    Shanghai, 200025

  • Local Institution

    Shenyang, Liaoning, 110000

  • Local Institution

    Shenyang, Liaoning, 110004

  • Local Institution

    Shenzhen, Guangdong, 518114

  • Local Institution

    Suzhou, Jiangsu, 215006

  • Local Institution

    Taiyuan, Shan1xi, 030001

  • Local Institution

    Tianjin, Tianjin Municipality, 300170

  • Local Institution

    Tianjin, Tianjin Municipality, 300192

  • Local Institution

    Wuhan, Hubei, 430022

  • Local Institution

    Xi'an, Shan3xi, 710038

  • Local Institution

    Xi'an, Shan3xi, 710061

  • Local Institution

    Zhengzhou, Henan, 450003

  • Local Institution

    Zhengzhou, Henan, 450052

Other trials in China

South Korea39 sites

  • Local Institution

    Ansan-si, Gyeonggi-do, 425-707

  • Local Institution

    Bucheon-si, 402-767

  • Local Institution

    Busan, 602-702

  • Local Institution

    Busan, 602-715

  • Local Institution

    Busan, 602-739

  • Local Institution

    Busan, 614-735

  • Local Institution

    Chuncheon, 200-704

  • Local Institution

    Chungju, 380-060

  • Local Institution

    Daegu, 700-712

  • Local Institution

    Daegu, 705-718

  • Local Institution

    Daejeon, 301-723

  • Local Institution

    Daejeon, 302-721

  • Local Institution

    Gangneung-si, 210-711

  • Local Institution

    Goyang, 411-719

  • Local Institution

    Gwangju, 503-715

  • Local Institution

    Gyeonggi-do, 410-769

  • Local Institution

    Gyeongju, 780-350

  • Local Institution

    Incheon, 400-711

  • Local Institution

    Incheon, 405-760

  • Local Institution

    Jinju, 660-702

  • Local Institution

    Koyang City, 411-706

  • Local Institution

    Seoul, 120-749

  • Local Institution

    Seoul, 130-702

  • Local Institution

    Seoul, 134-080

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 135-720

  • Local Institution

    Seoul, 137-040

  • Local Institution

    Seoul, 138-736

  • Local Institution

    Seoul, 140-743

  • Local Institution

    Seoul, 150-071

  • Local Institution

    Seoul, 150-713

  • Local Institution

    Seoul, 152-703

  • Local Institution

    Sungnam, 463-712

  • Local Institution

    Sungnam-si, 463-774

  • Local Institution

    Suwon, 442-723

  • Local Institution

    Suwon, 443-721

  • Local Institution

    Uijeongbu-si, Gyeonggi-do, 480-717

  • Local Institution

    Ulsan, 682-714

  • Local Institution

    Wŏnju, 220-701

Other trials in South Korea

Brazil30 sites

  • Local Institution

    Belém, Pará, 66035-080

  • Local Institution

    Belo Horizonte, Minas Gerais, 30110-934

  • Local Institution

    Belo Horizonte, Minas Gerais, 30130-100

  • Local Institution

    Belo Horizonte, Minas Gerais, 30150-221

  • Local Institution

    Campinas, São Paulo, 13060-904

  • Local Institution

    Campinas, São Paulo, 13083-888

  • Local Institution

    Cuiabá, Mato Grosso, 78048-902

  • Local Institution

    Curitiba, Paraná, 80240-280

  • Local Institution

    Goiânia, Goiás, 74605-050

  • Local Institution

    Ipatinga, Minas Gerais, 35160-118

  • Local Institution

    Juiz de Fora, Minas Gerais, 36021-630

  • Local Institution

    Manaus, Amazonas, 69040-000

  • Local Institution

    Marília, São Paulo, 17519-000

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution

    Porto Alegres/rs, Rio Grande do Sul, 90020-090

  • Local Institution

    Recife, Pernambuco, 50100-130

  • Local Institution

    Ribeirão Preto, 14048-900

  • Local Institution

    Rio Branco, Acre, 69914-220

  • Local Institution

    Rio de Janeiro, 20020

  • Local Institution

    Rio de Janeiro, 20270-004

  • Local Institution

    Rio de Janeiro / Rj, Rio de Janeiro, 21041-030

  • Local Institution

    Salvador, Estado de Bahia, 40110-060

  • Local Institution

    Salvador, Estado de Bahia, 40110-160

  • Local Institution

    Santo Andre - Sp, São Paulo, 09060-870

  • Local Institution

    São José, Santa Catarina, 88103-400

  • Local Institution

    São José do Rio Preto, São Paulo, 15090-000

  • Local Institution

    São Paulo, São Paulo, 05403-000

  • Local Institution

    São Paulo, 02128-000

  • Local Institution

    Sorocaba, São Paulo, 18047-600

Other trials in Brazil

India29 sites

  • Local Institution

    Ahemedabad, Gujarat, 380 006

  • Local Institution

    Ahmedabad, Gujarat, 380006

  • Local Institution

    Bangalore, Karnataka, 560 054

  • Local Institution

    Bangalore, Karnataka, 560034

  • Local Institution

    Bhopal, Madhya Pradesh, 462016

  • Local Institution

    Chennai, Tamil Nadu, 600096

  • Local Institution

    Coimbatore, 641015

  • Local Institution

    Gurgaon, Haryana, 122001

  • Local Institution

    Hyderabad, Andhra Pradesh, 500012

  • Local Institution

    Hyderabad, Andhra Pradesh, 500034

  • Local Institution

    Hyderabad, Andhra Pradesh, 500068

  • Local Institution

    Hyderabad, Andhra Pradesh, 500082

  • Local Institution

    Hyderabad, 500058

  • Local Institution

    Indore, 452014

  • Local Institution

    Jaipur, Rajasthan, 302017

  • Local Institution

    Kochi, Kerala, 682304

  • Local Institution

    Kolkata, 700054

  • Local Institution

    Lucknow, Uttar Pradesh, 226014

  • Local Institution

    Ludhiana, Punjab, 141001

  • Local Institution

    Ludhiana, 141008

  • Local Institution

    Madurai, Tamil Nadu, 625002

  • Local Institution

    Madurai, Tamil Nadu, 625107

  • Local Institution

    Mangalore, Karnataka, 575002

  • Local Institution

    Mumbai, 400008

  • Local Institution

    Nagpur, Maharashtra, 440012

  • Local Institution

    Nashik, Maharashtra, 422002

  • Local Institution

    New Delhi, 110002

  • Local Institution

    Secunderabad, Andhra Pradesh, 500003

  • Local Institution

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

United States20 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Rush University Med Ctr

    Chicago, Illinois, 60612

  • Scti Research Foundation

    Coronado, California, 92118

  • UT Southwestern Medical Center

    Dallas, Texas, 7390-8887

  • University Of Connecticut Health Center

    Farmington, Connecticut, 06030-1845

  • Medical Procare, Pllc

    Flushing, New York, 11355

  • Office Of Sing Chan Md

    Flushing, New York, 11355

  • Indiana University

    Indianapolis, Indiana, 46202-5121

  • Cedars-Sinai Comprehensive Transplant Center

    Los Angeles, California, 90048

  • University Of Miami Center For Liver Diseases

    Miami, Florida, 33136

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Beth Israel Medical Center

    New York, New York, 10003

  • Va New York Harbor Healthcare System

    New York, New York, 10010

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112-4481

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Phgi Associates, Ltd

    Philadelphia, Pennsylvania, 19106

  • Thomas Jefferson Medical College

    Philadelphia, Pennsylvania, 19107

  • Upmc Center For Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Kaiser Permanente Medical Center

    San Francisco, California, 94118

Other trials in United States

Russia14 sites

  • Local Institution

    Arkhangelsk, 163045

  • Local Institution

    Irkutsk, 664047

  • Local Institution

    Kazan', Tatarstan Republic, 420097

  • Local Institution

    Kirov, 610000

  • Local Institution

    Krasnoyarsk, 660014

  • Local Institution

    Lipetsk, 398043

  • Local Institution

    Moscow, 119021

  • Local Institution

    Moscow, 119435

  • Local Institution

    Moscow, 125367

  • Local Institution

    Nizhniy Novgord, 603076

  • Local Institution

    Nizhny Novgorod, 603022

  • Local Institution

    Ryazan, 390005

  • Local Institution

    Samara, 430063

  • Local Institution

    Yakutsk, 677005

Other trials in Russia

Mexico12 sites

  • Local Institution

    Boca del Rio, Veracruz, 94298

  • Local Institution

    Cuernavaca, Morelos, 62170

  • Local Institution

    Culiacan, Sin., Sinaloa, 80230

  • Local Institution

    Distrito Federal, 14080

  • Local Institution

    Durango, 34208

  • Local Institution

    Guadalajara, Jalisco, 44160

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    Monterrey, Nuevo León, 64710

  • Local Institution

    Monterrey, N.l., Nuevo León, 64460

  • Local Institution

    Saltillo, Coahuila, 25000

  • Local Institution

    Zapopan, Jalisco, 45116

  • Local Institution

    Zapopan, Jalisco, 45200

Other trials in Mexico

Taiwan10 sites

  • Local Institution

    Kaohsiung City, 80756

  • Local Institution

    Kaohsiung City, 833

  • Local Institution

    Taichung, 402

  • Local Institution

    Taichung, 404

  • Local Institution

    Taichung, 40705

  • Local Institution

    Tainan, 70428

  • Local Institution

    Taipei, 100

  • Local Institution

    Taipei, 10650

  • Local Institution

    Taipei, 112

  • Local Institution

    Young Kang City, 710

Other trials in Taiwan

France9 sites

  • Local Institution

    Créteil, 94010

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Lille, 59037

  • Local Institution

    Limoges, 87042

  • Local Institution

    Lyon, 69004

  • Local Institution

    Paris, 75014

  • Local Institution

    Paris, 75020

  • Local Institution

    Paris, 75651

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Argentina8 sites

  • Local Institution

    Buenos Aires, 1181

  • Local Institution

    Buenos Aires, 1221

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, 1155

  • Local Institution

    El Palomar, Buenos Aires, 1684

  • Local Institution

    Neuquén, 8300PMB

  • Local Institution

    Salta, Salta Province, A4406CLA

  • Local Institution

    San Salvador de Jujuy, Jujuy Province, Y4600ADE

  • Local Institution

    Villa Nueva, Mendoza Province, 5519

Other trials in Argentina

Romania8 sites

  • Local Institution

    Bucharest, 020125

  • Local Institution

    Bucharest, 021105

  • Local Institution

    Bucharest, 022328

  • Local Institution

    Bucharest, 030303

  • Local Institution

    Bucharest, 050098

  • Local Institution

    Constanța, 900591

  • Local Institution

    Iași, 700111

  • Local Institution

    Timișoara, 300723

Other trials in Romania

Germany7 sites

  • Local Institution

    Berlin, 10117

  • Local Institution

    Bonn, 53105

  • Local Institution

    Düsseldorf, 40225

  • Local Institution

    Hamburg, 20099

  • Local Institution

    Leipzig, 04103

  • Local Institution

    Tübingen, 72076

  • Local Institution

    Würzburg, 97080

Other trials in Germany

Philippines7 sites

  • Local Institution

    Cebu City, 6000

  • Local Institution

    Davao City, 8000

  • Local Institution

    Ermita Manila, 1000

  • Local Institution

    Manila, 1000

  • Local Institution

    Manila, 1003

  • Local Institution

    Metro Manila, 1500

  • Local Institution

    Quezon City, 1100

Other trials in Philippines

Poland7 sites

  • Local Institution

    Krakow, 31-202

  • Local Institution

    Krakow, 31-501

  • Local Institution

    Lodz, 91-347

  • Local Institution

    Poznan, 61-285

  • Local Institution

    Racibórz, 47-400

  • Local Institution

    Szczecin, 71-455

  • Local Institution

    Zawiercie, 42-400

Other trials in Poland

Spain7 sites

  • Local Institution

    Granada, 18012

  • Local Institution

    Madrid, 28006

  • Local Institution

    Madrid, 28222

  • Local Institution

    Oviedo, 33006

  • Local Institution

    San Sebastian Guipuzcuoa, 20014

  • Local Institution

    Seville, 41014

  • Local Institution

    Valencia, 46010

Other trials in Spain

Turkey (Türkiye)7 sites

  • Local Institution

    Adana, 01330

  • Local Institution

    Ankara, 06100

  • Local Institution

    Eskişehir, 26480

  • Local Institution

    Izmir, 35100

  • Local Institution

    Izmir, 35120

  • Local Institution

    Kayseri, 38039

  • Local Institution

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Thailand6 sites

  • Local Institution

    Bangkok, 10330

  • Local Institution

    Bangkok, 10400

  • Local Institution

    Bangkok, 10700

  • Local Institution

    Hat Yai, Changwat Songkhla, 90110

  • Local Institution

    Khon Kaen, 40002

  • Local Institution

    Pathum Thani, 12120

Other trials in Thailand

Canada5 sites

  • Local Institution

    Calgary, Alberta, T2N 4Z6

  • Local Institution

    Edmonton, Alberta, T6G 2E1

  • Local Institution

    Montreal, Quebec, H2X 3J4

  • Local Institution

    Toronto, Ontario, M5G 2C4

  • Local Institution

    Vancouver, British Columbia, V5Z 1H2

Other trials in Canada

Czechia5 sites

  • Local Institution

    Brno, 625 00

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Ostrava, 708 52

  • Local Institution

    Prague, 180 81

  • Local Institution

    Ústí nad Labem, 400 01

Other trials in Czechia

Greece4 sites

  • Local Institution

    Alexandroupoli, 68100

  • Local Institution

    Athens, Kolonaki, 10676

  • Local Institution

    Athens, 11522

  • Local Institution

    Athens, 11527

Other trials in Greece

Portugal4 sites

  • Local Institution

    Braga, 4701-965

  • Local Institution

    Coimbra, 3050-075

  • Local Institution

    Lisbon, 1169-050

  • Local Institution

    Porto, 4200-319

Other trials in Portugal

Italy3 sites

  • Local Institution

    Bologna, 40138

  • Local Institution

    Naples, 80131

  • Local Institution

    Rome, 00149

Other trials in Italy

Colombia2 sites

  • Local Institution

    Bogota, Cundinamarca

  • Local Institution

    Bogotá

Other trials in Colombia

Singapore1 site

  • Local Institution

    Singapore, 119228

Other trials in Singapore

About this study

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

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.

Being tested
entecavir, Other anti-HBV medication
Keywords
Chronic Hepatitis B Virus
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 Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision

  • Other anti-HBV medicationDrug

    Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision

Study groups in NCT00388674
Study groupRoleWhat they receive
ANot described
Receives: Drug: entecavir
BNot described
Receives: Drug: Other anti-HBV medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adjudicated Overall Malignant Neoplasms

    The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)

    Measured: 10 years

  2. Number of Deaths

    The number of deaths, as adjudicated by Events Adjudication Committee (EAC)

    Measured: 10 years

  3. 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)

    Measured: 10 years

Secondary outcomes (3)

  1. Number of Participants With Non-HCC Malignant Neoplasm

    The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)

    Measured: 10 years

  2. Number of Participants With HCC Malignant Neoplasm

    The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)

    Measured: 10 years

  3. Number of Participants With Liver-related Death

    The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2006 (estimated)
  2. Study start18 Dec 2006
  3. Primary completion26 Oct 2016
  4. Study completion26 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12,522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388674
Sponsor's protocol ID
AI463-080
Status last verified
Oct 2017
First submitted
4 Oct 2006
Last updated
30 Jul 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 33447520

  • 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.

    PubMed 31306800

  • 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.

    PubMed 23876210

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis B, run by Bristol-Myers Squibb at 290 sites in 24 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 4 inclusion and 12 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 290 sites in China, South Korea, Brazil, India, United States and 19 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2018). 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?

Number of Participants With Adjudicated Overall Malignant Neoplasms (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT00388674, which also lists 3 linked publications.

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 30 Jul 2018.

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