Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters

Completed

• Conditions: Hepatitis B; Liver Fibrosis

• Registration Number: NCT01962155
• Lead Sponsor: Peking University First Hospital

Brief Summary

The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China.

Detailed Description

Up to Oct, 2015,total of 1800 patients with chronic HBV infection were enrolled. Paired blood and liver biopsy samples were collected. Blood samples stored at -80 degree Celsius. Liver biopsy samples were judged by three pathology experts.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-05
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-14
• Primary Completion: 2015-12
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1841

Inclusion Criteria

1. HBsAg positive for at least 6 months
2. agree to have liver biopsy
3. Male or female aged 18 to 65 years old

Exclusion Criteria

1. Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
2. platelet count < 80000/L
3. prothrombin activity ≤ 60%
4. patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis B	singular evaluation at the time of liver biopsy

Trial Locations

Locations (30)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Peking University First Hospital; 🇨🇳 Bei Jing, Beijing, China

302 Military Hospital of China; 🇨🇳 Beijing, Beijing, China

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

Southwest Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Guangzhou Eighth People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The Third people's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China

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