Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention

Sponsor

Beijing Ditan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04030039

Collaborator

(none)

420

Enrollment

Location

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B Infection	Drug: Interferon Drug: nucleoside analogues

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

420 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
chronic hepatitis B patients during the immune control period Patients with chronic HBV infection during the immune control period do not have any clinical treatment intervention cohort
Therapy group A After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with interferon	Drug: Interferon chronic hepatitis B patients with interferon therapy
Therapy group B After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they stopped to be treated with interferon	Drug: Interferon chronic hepatitis B patients with interferon therapy
Therapy group C After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential nucleoside analogues	Drug: Interferon chronic hepatitis B patients with interferon therapy Drug: nucleoside analogues chronic hepatitis B patients with interferon therapy
Therapy group D After chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential interferon	Drug: Interferon chronic hepatitis B patients with interferon therapy Drug: nucleoside analogues chronic hepatitis B patients with interferon therapy
Therapy group E After chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with the nucleoside analogues	Drug: nucleoside analogues chronic hepatitis B patients with interferon therapy

Outcome Measures

Primary Outcome Measures

The incidence of HBsAg disappearance during the 96-week study in different observation cohorts [96 weeks]
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts

Secondary Outcome Measures

HBV DNA re-yang rate during the 96-week study period in different observation cohorts [96 weeks]
HBV DNA re-yang rate and HBeAg re-yang rate during the 96-week study period in different observation cohorts
HBeAg re-yang rate during the 96-week study [96 weeks]
HBeAg re-yang rate during the 96-week study

Other Outcome Measures

liver cancer during the 96-week study period in different observation cohorts Incidence [96 weeks]
liver cancer during the 96-week study period in different observation cohorts Incidence
Hepatitis episodes during the 96-week study period in different observation cohorts Incidence [96 weeks]
Hepatitis episodes during the 96-week study period in different observation cohorts Incidence
cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence [96 weeks]
cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence
its complications during the 96-week study period in different observation cohorts Incidence [96 weeks]
its complications during the 96-week study period in different observation cohorts Incidence

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.