Clinical trial NCT04030039: Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention
Official title: Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B Infection
Keywords: Chronic hepatitis B
interferon
nucleotide
HBV
HBsAg
HBV DNA
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic hepatitis B patients with HBsAg \< 100 IU/ml in an inactive carrying state were enrolled and treated with antiviral therapy (interferon and nucleoside analogs). All patients with chronic hepatitis B infection were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).

Brief summary: All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg\<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) CHB patients in the immunological control period, without any clinical treatment intervention; 2) After interferon therapy, HBsAg\<100 IU/ml, continued interferon therapy; 3) After interferon therapy, HBsAg\<100 IU/ml, stopped interferon treatment; 4) After interferon therapy, HBsAg\<100 IU/ml, sequential nucleoside analog treatment; 5) After nucleoside analogue treatment, HBsAg\<100 IU/ml, sequential interferon treatment; 6) After treated with nucleoside analogues, HBsAg\<100 IU/ml, continuing the nucleoside analog treatment. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV indicators and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.

Detailed description: This study is a clinical observational cohort study. All chronic hepatitis B patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg\<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) chronic Hepatitis B patients in the immunological control period, without any clinical treatment intervention in this cohort; 2) After interferon therapy, HBsAg\<100 IU/ml, continued interferon therapy in this cohort; 3) After interferon therapy, HBsAg\<100 IU/ml, stopped interferon treatment in this cohort; 4) After interferon therapy, HBsAg\<100 IU/ml, sequential nucleoside analog treatment in this cohort; 5) After nucleoside analogue treatment, HBsAg\<100 IU/ml, sequential interferon treatment in this cohort; 6) After treated with nucleoside analogues, HBsAg\<100 IU/ml, continuing the nucleoside analog treatment in this cohort. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV DNA loads, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.

Eligibility criteria: Inclusion Criteria:

* Inactive carrier status and chronic hepatitis B (CHB) patients with anti-viral therapy (interferon and nucleoside analogues) reaching HBsAg \< 100 IU/ml.

Exclusion Criteria:

* coinfection with other viruses including HCV, HDV, and HIV;
* syphilis antibody positive;
* co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease;
* complication of cirrhosis or liver cancer.

Primary outcomes:
measure: The incidence of HBsAg disappearance during the 96-week study in different observation cohorts
timeFrame: 96 weeks
Secondary outcomes:
measure: HBV DNA re-yang rate during the 96-week study period in different observation cohorts
timeFrame: 96 weeks
measure: HBeAg re-yang rate during the 96-week study
timeFrame: 96 weeks
Other outcomes:
measure: liver cancer during the 96-week study period in different observation cohorts Incidence
timeFrame: 96 weeks
measure: Hepatitis episodes during the 96-week study period in different observation cohorts Incidence
timeFrame: 96 weeks
measure: cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence
timeFrame: 96 weeks
measure: its complications during the 96-week study period in different observation cohorts Incidence
timeFrame: 96 weeks
Locations:
city: Beijing
country: China
facility: liver disease center, Beijing Ditan Hospital
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital, Beijing, China
name: Yao Xie
role: PRINCIPAL_INVESTIGATOR
References: