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

Capital Medical University

Status: Active, not recruiting

Conditions: Chronic Hepatitis B

Treatments: Drug: Nucleos(t)ide Analogues

Study type: Observational

Funder types: Other

Identifiers

NCT03366571

D161100002716003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Anti-viral therapy group

Description:

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"

Treatment:

Drug: Nucleos(t)ide Analogues

Non anti-viral therapy group

Description:

History study from literature