Observational Study on Patients With Chronic Hepatitis B

• Conditions: Chronic Hepatitis B

• Registration Number: NCT02167503
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-17
• Last Update Submitted: 2014-06-17
• Study First Posted: 2014-06-19
• Last Update Posted: 2014-06-19
• Primary Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative rates of hepatocellular carcinoma	Year 5

Trial Locations

Locations (14)

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital Attached to the Capital Medical University; 🇨🇳 Beijing, Beijing, China

Department of infectious disease, First Hospital of Peking University; 🇨🇳 Beijing, Beijing, China

BeiJing YouAn Hospital ,Capital Medical University; 🇨🇳 BeiJing, Beijing, China

People's Hospital of Beijing University; 🇨🇳 Beijing, Beijing, China

Department of infectious disease, Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Third Hospital of Sun Yat-Sen University; 🇨🇳 GuangZhou, Guangdong, China

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Xiangya Hospital Central-South Univrsity; 🇨🇳 ChangSha, Hunan, China

First Hospital .Jilin Unniversity; 🇨🇳 ChangChun, Jilin, China

ShengJing Hospital of China Medical University; 🇨🇳 ShenYang, Liaoning, China

The First Affiliated Hospital of College of Medicine ，Zhejiang University; 🇨🇳 HangZhou, Zhejiang, China

Shanghai Ruijin Hospital; 🇨🇳 ShangHai, Shanghai, China

Huashan Hospital，Fudan University; 🇨🇳 ShangHai, Shanghai, China