Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B
NCT04028856 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2019-07-23
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.
Conditions
Interventions
- DRUG
-
interferon
Chronic hepatitis B patients were treated with interferon for 48 weeks
Sponsors & Collaborators
-
Beijing Ditan Hospital
lead OTHER
Principal Investigators
-
Yao Xie, Doctor · Department of hepatology Division 2, Beijing Ditan Hospital, Capital Medical University
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-01
- Primary Completion
- 2019-06-30
- Completion
- 2019-06-30
Countries
- China
Study Locations
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