Clinical trial NCT02167503: Observational Study on Patients With Chronic Hepatitis B
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: National Health and Family Planning Commission, P.R.China
First posted: 2014-06-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B from hospital

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


Eligibility 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

Primary outcomes:
measure: Cumulative rates of hepatocellular carcinoma
timeFrame: Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Attached to the Capital Medical University
state: Beijing
city: BeiJing
country: China
facility: BeiJing YouAn Hospital ,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of infectious disease, First Hospital of Peking University
state: Beijing
city: Beijing
country: China
facility: People's Hospital of Beijing University
state: Beijing
city: Guangzhou
country: China
facility: Department of infectious disease, Nanfang Hospital
state: Guangdong
city: GuangZhou
country: China
facility: The Third Hospital of Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: ChangSha
country: China
facility: Xiangya Hospital Central-South Univrsity
state: Hunan
city: ChangChun
country: China
facility: First Hospital .Jilin Unniversity
state: Jilin
city: ShenYang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
city: ShangHai
country: China
facility: Huashan Hospital，Fudan University
state: Shanghai
city: ShangHai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: HangZhou
country: China
facility: The First Affiliated Hospital of College of Medicine ，Zhejiang University
state: Zhejiang
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou, MD
role: PRINCIPAL_INVESTIGATOR
References: