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

Chronic Hepatitis B Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030039
• Other study ID #: DTXY017
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2019
• Source: Beijing Ditan Hospital
• Contact: Yao Xie, Doctor
• Phone: 010-84322284
• Email: xieyao00120184[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B Infection
• Communicable Diseases
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• Interferon
chronic hepatitis B patients with interferon therapy
• nucleoside analogues
chronic hepatitis B patients with interferon therapy

Locations

Country	Name	City	State
China	liver disease center, Beijing Ditan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	liver cancer during the 96-week study period in different observation cohorts Incidence	liver cancer during the 96-week study period in different observation cohorts Incidence	96 weeks
Other	Hepatitis episodes 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
Other	cirrhosis decompensation 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
Other	its complications 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
Primary	The incidence of HBsAg disappearance during the 96-week study in different observation cohorts	The incidence of HBsAg disappearance during the 96-week study in different observation cohorts	96 weeks
Secondary	HBV DNA re-yang rate during the 96-week study period in different observation cohorts	HBV DNA re-yang rate and HBeAg re-yang rate during the 96-week study period in different observation cohorts	96 weeks
Secondary	HBeAg re-yang rate during the 96-week study	HBeAg re-yang rate during the 96-week study	96 weeks