Hepatitis B, Chronic Clinical Trial
Official title:
A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study
NCT number | NCT02974829 |
Other study ID # | AI463520 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | November 23, 2016 |
Last updated | November 23, 2016 |
Start date | May 2016 |
The purpose of this study is to conduct an investigator initiated observational study to continue to follow up the China subset of study participants for another 5 years after they complete participation in the REALM Study
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Patients completed REALM Study in China 2. Patients willing to sign the consent to continue anti-viral treatment or post-treatment follow up, and agree his/her legacy data and blood/liver histology samples collected in REALM Study may be used for the analyses planned for this new study. Exclusion Criteria: 1. Patients who do not provide consent to participate in this study; 2. Patients are formally enrolled into any investigational drug clinical trial after the REALM study. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | 302 Military Hospital Of China | Beijing | Beijing |
China | Beijing Ditan Hospital | Beijing | Beijing |
China | Beijing Friendship Hospital | Beijing | Beijing |
China | First Affiliated Hospital of Beijing University | Beijing | |
China | People's Hospital of Beijing University | Beijing | Beijing |
China | You An Hospital | Beijing | |
China | First Hospital of Jilin Unniversity | Changchun | Jilin |
China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
China | Xiangya Hospital Central South University | Changsha | Hunan |
China | West China Hospital of SiChuan University | Chengdu | Sichuan |
China | Southwest Hospital Affiliated the Third Military Medical University | Chongqing | |
China | The Second Affiliated of ChongQing University of Medical Science | Chongqing | Chongqing |
China | No.6 People's hospital of Dalian | Dalian | Liaoning |
China | GuangZhou No. 8 People's Hospital | Guangzhou | Guangdong |
China | Nanfang Hospital | Guangzhou | Guangdong |
China | Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
China | Affiliated Hospital of Guiyang Medical College | Guiyang | Guizhou |
China | People's hospital of Hainan Province | Haikou | Hainan |
China | First Affiliated Hospital of Zhejing University | Hangzhou | Zhejiang |
China | Hangzhou No.6 people's hospital | Hangzhou | Zhejiang |
China | First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
China | Jinan infectious disease hospital | Jinan Shi | Shandong |
China | The first affiliated hospital of kunming medical college | Kunming | Yunnan |
China | No.81 Hospital of PLA | Nanjing | Jiangsu |
China | The second hospital of nanjing | Nanjing | Jiangsu |
China | Ningbo infectious disease hospital | Ningbo | Jiangsu |
China | Changhai Hospital of the Second Military Medical University of Chinese PLA | Shanghai | |
China | Huashan hospital of fudan university | Shanghai | |
China | No.85 Hospital of PLA | Shanghai | Shanghai |
China | Renji Hospital of Shanghai Jiao Tong University | Shanghai | |
China | Shanghai jing 'an district central hospital | Shanghai | |
China | Shanghai No.5 People's Hospital | Shanghai | |
China | Shanghai Public Health Clinical Center | Shanghai | |
China | Shanghai Ruijin Hospital | Shanghai | Shanghai |
China | Zhongshan Hospital of Fudan University | Shanghai | |
China | ShengJing Hospital of China Medical University | Shengyang | Liaoning |
China | No.6 People's hospital of Shenyang | Shenyang | Liaoning |
China | No.3 people's hospital of shenzhen | Shenzhen | |
China | First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
China | People's hospital of Jiangsu Province | Suzhou | Jiangsu |
China | First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang |
China | Tianjin infectious disease hospital | Tianjin | |
China | Tianjin third central hospital | Tianjin | |
China | Tongji Hospital of Huazhong University of Science and Technology | Wuhan | Hubei |
China | Tangdu Hospital | Xi'an | Shaanxi |
China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
China | First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
China | Medical Science Research Institute of Henan Province | Zhengzhou | Henan |
China | People's Hospital of Henan Province | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University | Bristol-Myers Squibb |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment patterns in Study AI463520 | year 5 | No | |
Primary | Incidence rates of hepatitis B virus (HBV)-related clinical outcome events (COEs), such as non-hepatocellular carcinoma (HCC) HBV progression, HCC, and liver-related mortality, in Studies AI463080 and AI463520 combined, and in Study AI463520. | year 5 | No | |
Secondary | Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520. | year 5 | No | |
Secondary | Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study | year 5 | No | |
Secondary | Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520. | year 5 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03272009 -
Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects
|
Phase 1 | |
Recruiting |
NCT01456312 -
HBsAg Related Response Guided Therapy
|
Phase 4 | |
Terminated |
NCT01886300 -
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
|
N/A | |
Completed |
NCT01023230 -
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
|
Phase 1 | |
Completed |
NCT00962975 -
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
|
Phase 1 | |
Completed |
NCT00536263 -
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
|
Phase 3 | |
Terminated |
NCT00460850 -
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
|
Phase 4 | |
Completed |
NCT03681132 -
The Norwegian Nucleoside Analogue Stop Study
|
Phase 4 | |
Active, not recruiting |
NCT05473806 -
Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
|
Phase 4 | |
Withdrawn |
NCT01179594 -
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
|
Phase 4 | |
Recruiting |
NCT05057065 -
A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
|
||
Completed |
NCT04439539 -
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Withdrawn |
NCT03125213 -
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
|
Phase 2 | |
Active, not recruiting |
NCT04782375 -
Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B
|
Phase 4 | |
Withdrawn |
NCT05550519 -
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
|
Early Phase 1 | |
Completed |
NCT02693652 -
A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT04160897 -
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
|
||
Active, not recruiting |
NCT02588937 -
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
|
Phase 4 | |
Completed |
NCT02612506 -
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT02327416 -
A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)
|
Phase 3 |