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出境医 / 临床实验 / Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B

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

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
Chronic Hepatitis B Drug: interferon

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.
Study Design
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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 : June 1, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019
Arms and Interventions
Group/Cohort 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 :
  1. Rate of disappearance of HBsAg [ Time Frame: after 48 weeks of treatment ]
    Rate of disappearance of HBsAg after 48 weeks of treatment


Secondary Outcome Measures :
  1. HBeAg seroconversion rate [ Time Frame: at the treatment of 48 weeks ]
    Treatment of 48 weeks HBeAg seroconversion rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.
Contacts and Locations

Locations
Layout table for location information
China, Beijing
liver disease center, Beijing Ditan Hospital
Beijing, Beijing, China, 100015
Sponsors and Collaborators
Beijing Ditan Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yao Xie, Doctor Department of hepatology Division 2, Beijing Ditan Hospital, Capital Medical University
Tracking Information
First Submitted Date July 20, 2019
First Posted Date July 23, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date June 1, 2018
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2019) 		Rate of disappearance of HBsAg [ Time Frame: after 48 weeks of treatment ]
Rate of disappearance of HBsAg after 48 weeks of treatment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 20, 2019) 		HBeAg seroconversion rate [ Time Frame: at the treatment of 48 weeks ]
Treatment of 48 weeks HBeAg seroconversion rate
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Chronic Hepatitis B
Intervention Drug: interferon
Chronic hepatitis B patients were treated with interferon for 48 weeks
Study Groups/Cohorts
  • Continuous interferon treatment group
    Patients with chronic hepatitis B treated with continuous interferon for 48 weeks
    Intervention: Drug: interferon
  • 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
    Intervention: Drug: interferon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 20, 2019) 		400
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04028856
Other Study ID Numbers DTXY019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yao Xie, Beijing Ditan Hospital
Study Sponsor Beijing Ditan Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yao Xie, Doctor Department of hepatology Division 2, Beijing Ditan Hospital, Capital Medical University
PRS Account Beijing Ditan Hospital
Verification Date July 2019

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