Observational Study on Patients With Chronic Hepatitis B

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)

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

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic hepatitis B from hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative rates of hepatocellular carcinoma	Year 5

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: National Health and Family Planning Commission, P.R.China

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 19, 2014

Study Record Updates

• Last Update Posted (Estimate): June 19, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• 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
• Other Study ID Numbers: MOH-08