Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B

Sponsor

Beijing Ditan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04028856

Collaborator

(none)

400

Enrollment

Location

12.9

Actual Duration (Months)

30.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was a retrospective clinical observational cohort study. All patients with chronic hepatitis B (CHB) whose HBsAg decreased by less than 10% were treated continuously with interferon in the Department of Hepatology, Beijing Ditan Hospital, Beijing Medical University, Beijing Capital University, 2008.10-2017.4. The total interferon treatment time of the enrolled subjects was 48 weeks. The subjects were randomly divided into the following two observation cohorts: 1) patients with chronic hepatitis B treated with continuous interferon for 48 weeks; 2) intermittent interferon For 48 weeks of treatment for patients with chronic hepatitis B, the interferon treatment interval was 3 months. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical markers, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline) and during treatment. The primary outcome measure was the rate at which HBsAg disappeared at 48 weeks of treatment. The secondary evaluation index was the 48-week HBeAg seroconversion rate. To investigate the efficacy, influencing factors and safety of interferon intermittent treatment of chronic hepatitis B.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: interferon

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Cohort Study on Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Continuous interferon treatment group Patients with chronic hepatitis B treated with continuous interferon for 48 weeks	Drug: interferon Chronic hepatitis B patients were treated with interferon for 48 weeks
Intermittent interferon treatment group patients with chronic hepatitis B treated with intermittent interferon for 48 weeks, in which interferon therapy was intermittent for 3 months	Drug: interferon Chronic hepatitis B patients were treated with interferon for 48 weeks

Arm

Intervention/Treatment

Continuous interferon treatment group

Patients with chronic hepatitis B treated with continuous interferon for 48 weeks

Drug: interferon

Chronic hepatitis B patients were treated with interferon for 48 weeks

Intermittent interferon treatment group

patients with chronic hepatitis B treated with intermittent interferon for 48 weeks, in which interferon therapy was intermittent for 3 months

Drug: interferon

Chronic hepatitis B patients were treated with interferon for 48 weeks

Outcome Measures

Primary Outcome Measures

Rate of disappearance of HBsAg [after 48 weeks of treatment]
Rate of disappearance of HBsAg after 48 weeks of treatment

Secondary Outcome Measures

HBeAg seroconversion rate [at the treatment of 48 weeks]
Treatment of 48 weeks HBeAg seroconversion rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients with chronic hepatitis B meet the diagnostic criteria of China Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)

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.