Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy

April 9, 2021 updated by: Jidong Jia, Beijing Friendship Hospital
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Beijing Ditan Hospital
      • Beijing, Beijing, China
        • Beijing Youan Hospital
      • Beijing, Beijing, China
        • Peking University People's Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The HBV-related chronic hepatitis /cirrhosis patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research.

Description

Inclusion Criteria:

  • Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.
  • Patients comply with the requirements of the trail voluntarily
  • Written informed consent

Exclusion Criteria:

  • Pregnant woman or patient with severe disease
  • Patients with poor adherence to the study
  • Patients not suitable for the study evaluated by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anti-viral therapy group
Subjects who have completed the 3 years research "Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis"
Drug: Nucleos(t)ide Analogues
Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.
Other Names:
  • Baraclude , et al
Non anti-viral therapy group
History study from literature

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death
Time Frame: 10 years
Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage)，and/or hepatocellular carcinoma， and/or liver related death after 10 years of antiviral treatment
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV-DNA undetectable rate
Time Frame: 10 years
HBV-DNA undetectable rate after 10 years of antiviral treatment
10 years
Decrease of transient elastography
Time Frame: 10 years
Decrease of transient elastography after 10 years of antiviral treatment
10 years
HBeAg seroconversion rate
Time Frame: 10 years
HBeAg seroconversion rate after 10 years of antiviral treatment
10 years
HBsAg seroconversion rate
Time Frame: 10 years
HBsAg seroconversion rate after 10 years of antiviral treatment
10 years
Decrease of Child-Pugh score
Time Frame: 10 years
Decrease of Child-Pugh score after 10 years of antiviral treatment
10 years
Decrease of MELD score
Time Frame: 10 years
Decrease of MELD score after 10 years of antiviral treatment
10 years
Improvement of life Quality assessed by SF-36
Time Frame: 10 years
Improvement of life Quality assessed by SF-36 after 10 years of antiviral treatment
10 years
Improvement of life Quality assessed by EQ-5D
Time Frame: 10 years
Improvement of life Quality assessed by EQ-5D after 10 years of antiviral treatment
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Collaborators

Peking University First Hospital
Peking University People's Hospital
Beijing YouAn Hospital
Beijing Ditan Hospital

Investigators

  • Principal Investigator: Dong J Jia, Doctor, Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D161100002716003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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