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

Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01962155
Acronym
HBV
Enrollment
1841
Registered
2013-10-14
Start date
2013-08-31
Completion date
2016-09-30
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Liver Fibrosis

Keywords

Fibrosis, Liver Cirrhosis, non-invasive, biopsy, hepatitis B virus

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.

Interventions

None listed

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 Bsingular evaluation at the time of liver biopsy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026