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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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"

Nucleos(t)ide Analogues

Intervention Type DRUG

Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.

Non anti-viral therapy group

History study from literature

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Baraclude , et al

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No