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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03366571

Collaborator

Peking University First Hospital (Other), Peking University People's Hospital (Other), Beijing YouAn Hospital (Other), Beijing Ditan Hospital (Other)

600

Enrollment

Locations

107

Duration (Months)

150

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: Nucleos(t)ide Analogues

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

HBV-DNA undetectable rate [10 years]
HBV-DNA undetectable rate after 10 years of antiviral treatment
Decrease of transient elastography [10 years]
Decrease of transient elastography after 10 years of antiviral treatment
HBeAg seroconversion rate [10 years]
HBeAg seroconversion rate after 10 years of antiviral treatment
HBsAg seroconversion rate [10 years]
HBsAg 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
Decrease of MELD score [10 years]
Decrease of MELD 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
Improvement of life Quality assessed by EQ-5D [10 years]
Improvement of life Quality assessed by EQ-5D after 10 years of antiviral treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034
2	Beijing Ditan Hospital	Beijing	Beijing	China
3	Beijing YouAn Hospital	Beijing	Beijing	China
4	Peking University People's Hopsital	Beijing	Beijing	China