NCT04030039

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 420 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B Infection

Interventions

Type	Name	Description
DRUG	Interferon	chronic hepatitis B patients with interferon therapy
DRUG	nucleoside analogues	chronic hepatitis B patients with interferon therapy

Timeline

• Start date: 2017-05-01
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2019-07-23
• Last updated: 2019-07-23

Locations

1 site across 1 country: China