Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04028856
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-07-20
Brief Title:
Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B
Sponsor:
Beijing Ditan Hospital
Organization:
Beijing Ditan Hospital
Study Overview
Official Title:
Cohort Study on Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 200810-20174 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 HBsAganti-HBs HBeAganti-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 200810-20174 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 HBsAganti-HBs HBeAganti-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None