Clinical trial NCT03366571: Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy
Official title: Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: Liver Cirrhosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University People's Hospital
name: Beijing YouAn Hospital
name: Beijing Ditan Hospital
First posted: 2017-12-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The HBV-related chronic hepatitis /cirrhosis patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death
timeFrame: 10 years
Secondary outcomes:
measure: HBV-DNA undetectable rate
timeFrame: 10 years
measure: Decrease of transient elastography
timeFrame: 10 years
measure: HBeAg seroconversion rate
timeFrame: 10 years
measure: HBsAg seroconversion rate
timeFrame: 10 years
measure: Decrease of Child-Pugh score
timeFrame: 10 years
measure: Decrease of MELD score
timeFrame: 10 years
measure: Improvement of life Quality assessed by SF-36
timeFrame: 10 years
measure: Improvement of life Quality assessed by EQ-5D
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing YouAn Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hopsital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Dong J Jia, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.