Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: Nucleos(t)ide Analogues
- Registration Number
- NCT03366571
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anti-viral therapy group Nucleos(t)ide Analogues 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"
- Primary Outcome Measures
Name Time Method Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death 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
- Secondary Outcome Measures
Name Time Method HBV-DNA undetectable rate 10 years HBV-DNA undetectable rate after 10 years of antiviral treatment
HBsAg seroconversion rate 10 years HBsAg seroconversion rate after 10 years of antiviral treatment
Decrease of MELD score 10 years Decrease of MELD score after 10 years of antiviral treatment
Improvement of life Quality assessed by EQ-5D 10 years Improvement of life Quality assessed by EQ-5D after 10 years of antiviral treatment
HBeAg seroconversion rate 10 years HBeAg seroconversion rate after 10 years of antiviral treatment
Decrease of Child-Pugh score 10 years Decrease of Child-Pugh score after 10 years of antiviral treatment
Improvement of life Quality assessed by SF-36 10 years Improvement of life Quality assessed by SF-36 after 10 years of antiviral treatment
Decrease of transient elastography 10 years Decrease of transient elastography after 10 years of antiviral treatment
Trial Locations
- Locations (4)
Beijing Ditan Hospital
🇨🇳Beijing, Beijing, China
Beijing YouAn Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hopsital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China