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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02167503
Other study ID # MOH-08
Secondary ID
Status Recruiting
Phase N/A
First received June 17, 2014
Last updated June 17, 2014
Start date May 2014

Study information

Verified date June 2014
Source Nanfang Hospital of Southern Medical University
Contact Jinlin Hou, MD
Phone 86-20-61641941
Email jlhousmu@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility 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 Design

Observational Model: Cohort


Locations

Country Name City State
China Beijing Ditan Hospital Beijing Beijing
China Beijing Friendship Hospital Attached to the Capital Medical University Beijing Beijing
China BeiJing YouAn Hospital ,Capital Medical University BeiJing Beijing
China Department of infectious disease, First Hospital of Peking University Beijing Beijing
China People's Hospital of Beijing University Beijing Beijing
China First Hospital .Jilin Unniversity ChangChun Jilin
China Xiangya Hospital Central-South Univrsity ChangSha Hunan
China Department of infectious disease, Nanfang Hospital Guangzhou Guangdong
China The Third Hospital of Sun Yat-Sen University GuangZhou Guangdong
China The First Affiliated Hospital of College of Medicine ,Zhejiang University HangZhou Zhejiang
China Huashan Hospital,Fudan University ShangHai Shanghai
China Shanghai Ruijin Hospital ShangHai Shanghai
China ShengJing Hospital of China Medical University ShenYang Liaoning
China Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University National Health and Family Planning Commission, P.R.China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative rates of hepatocellular carcinoma Year 5 No
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