Clinical trial NCT04028856: Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B
Official title: Cohort Study on Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B
interferon
intermittent
HBV
HBsAg
HBV DNA
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B (CHB) with a reduction in HBsAg of less than 10% were treated with interferon for 6 months. All patients with chronic hepatitis B were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of disappearance of HBsAg
timeFrame: after 48 weeks of treatment
Secondary outcomes:
measure: HBeAg seroconversion rate
timeFrame: at the treatment of 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: liver disease center, Beijing Ditan Hospital
state: Beijing
Study officials:
affiliation: Department of hepatology Division 2, Beijing Ditan Hospital, Capital Medical University
name: Yao Xie, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li M, Xie S, Bi X, Sun F, Zeng Z, Deng W, Jiang T, Lin Y, Yang L, Lu Y, Zhang L, Yi W, Xie Y. An optimized mode of interferon intermittent therapy help improve HBsAg disappearance in chronic hepatitis B patients. Front Microbiol. 2022 Aug 30;13:960589. doi: 10.3389/fmicb.2022.960589. eCollection 2022.