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

Capital Medical University

Status: Unknown

Conditions: Chronic Hepatitis B Infection

Treatments: Drug: Interferon; Drug: nucleoside analogues

Study type: Observational

Funder types: Other

Identifiers

NCT04030039

DTXY017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

420 participants in 6 patient groups

chronic hepatitis B patients during the immune control period

Description:

Patients with chronic HBV infection during the immune control period do not have any clinical treatment intervention cohort

Therapy group A

Description:

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

Treatment:

Drug: Interferon

Therapy group B

Description:

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

Treatment:

Drug: Interferon

Therapy group C

Description:

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

Treatment:

Drug: Interferon

Drug: nucleoside analogues

Therapy group D

Description:

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

Treatment:

Drug: Interferon

Drug: nucleoside analogues

Therapy group E

Description:

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

Treatment:

Drug: nucleoside analogues