Trial record 109 of 436 for:    hepatitis b | Open Studies

Observational Study on Patients With Chronic Hepatitis B

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Nanfang Hospital of Southern Medical University
Sponsor:
Collaborator:
National Health and Family Planning Commission, P.R.China
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT02167503
First received: June 17, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.


Condition
Chronic Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Retrospective-prospective Observational Study to Evaluate the Effect of Anti-viral Treatment on the Long-term Outcome in Patients With Chronic Hepatitis B (SEARCH-B Study)

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • Cumulative rates of hepatocellular carcinoma [ Time Frame: Year 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: May 2014
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic hepatitis B from hospital

Criteria

Inclusion Criteria:

  • Male or female, aged over 30 (inclusive) years of old
  • Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months)
  • For patients with HBsAg positive, patients should be undergoing anti-viral treatment
  • For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided.
  • Life expectancy is more than 1 year
  • Good treatment compliance.

Exclusion Criteria:

  • Patients has a history of diagnosis of hepatocellular carcinoma
  • Patients with Child Pugh C
  • Coinfected with HCV, HDV and HIV
  • Suffering from other serious disease
  • Taking part in other clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02167503

Contacts
Contact: Jinlin Hou, MD 86-20-61641941 jlhousmu@163.com
Contact: Jian Sun, MD 86-20-62787432 doctorsunjian@163.com

Locations
China, Beijing
BeiJing YouAn Hospital ,Capital Medical University Recruiting
BeiJing, Beijing, China
Contact: XinYue Chen, MD    13911212398      
Principal Investigator: XinYue Chen         
Department of infectious disease, First Hospital of Peking University Recruiting
Beijing, Beijing, China
Contact: Yanyan Yu, MD    13901194223      
Principal Investigator: Yanyan Yu, MD         
Beijing Friendship Hospital Attached to the Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Hong Ma, MD    13651096128      
Principal Investigator: hong ma, MD         
People's Hospital of Beijing University Recruiting
Beijing, Beijing, China
Contact: Lai Wei, MD         
Principal Investigator: Lai Wei, MD         
Principal Investigator: Hao Wang, MD         
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China
Contact: Jun Cheng, MD         
Principal Investigator: Jun Cheng, MD         
China, Guangdong
The Third Hospital of Sun Yat-Sen University Recruiting
GuangZhou, Guangdong, China
Contact: ZhiLiang Gao, MD    13902263533      
Principal Investigator: ZhiLiang GAo         
Department of infectious disease, Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jinlin Hou, MD         
Principal Investigator: Jinlin Hou, MD         
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Qin Ning    13971521450      
Principal Investigator: Qin Ning         
China, Hunan
Xiangya Hospital Central-South Univrsity Recruiting
ChangSha, Hunan, China
Contact: DeMing Tan, MD    13875986817      
Principal Investigator: DeMing Tan, MD         
China, Jilin
First Hospital .Jilin Unniversity Recruiting
ChangChun, Jilin, China
Contact: JunQi Niu, MD    13756661205      
Principal Investigator: JunQi Niu         
China, Liaoning
ShengJing Hospital of China Medical University Recruiting
ShenYang, Liaoning, China
Contact: XiaoGuang Dou, MD    13898867074      
Principal Investigator: XiaoGuang Dou         
China, Shanghai
Huashan Hospital,Fudan University Recruiting
ShangHai, Shanghai, China
Contact: GuangFeng Shi, MD    13817780666      
Principal Investigator: GuangFeng Shi, MD         
Shanghai Ruijin Hospital Recruiting
ShangHai, Shanghai, China
Contact: Qing Xie, MD    13651804273      
Principal Investigator: Qing Xie         
China, Zhejiang
The First Affiliated Hospital of College of Medicine ,Zhejiang University Recruiting
HangZhou, Zhejiang, China
Contact: JiFang Sheng, MD    13600519200      
Principal Investigator: JiFang Sheng         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
National Health and Family Planning Commission, P.R.China
Investigators
Principal Investigator: Jinlin Hou, MD Nanfang Hospital of Southern Medical University
  More Information

No publications provided

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02167503     History of Changes
Other Study ID Numbers: MOH-08
Study First Received: June 17, 2014
Last Updated: June 17, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on October 19, 2014