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

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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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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