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NCT Number: NCT04028856

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon

Drug

Chronic hepatitis B patients were treated with interferon for 48 weeks

Primary outcomes

  1. Rate of disappearance of HBsAg

    Time frame: after 48 weeks of treatment

    Rate of disappearance of HBsAg after 48 weeks of treatment

Secondary outcomes

  1. HBeAg seroconversion rate

    Time frame: at the treatment of 48 weeks

    Treatment of 48 weeks HBeAg seroconversion rate

Sponsors and collaborators

Lead sponsor

Beijing Ditan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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