Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04301908
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2020-03-05
Brief Title:
A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
Sponsor:
Beijing Ditan Hospital
Organization:
Beijing Ditan Hospital
Study Overview
Official Title:
The Observational Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
NOT_YET_RECRUITING
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 was a retrospective observational cohort study The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease Beijing Ditan Hospital Capital Medical University from October 2008 to April 2020 were enrolled Patients treated with antiviral drugs including interferon andor nucleoside acid analogues lasting more than 6 months were included in the study Interferon nucleoside acid analogue monotherapy combination therapy sequential therapy maintenance therapy and drug withdrawal therapy can all be included in the study HBV DNA content HBsAganti-HBs HBeAganti-HBe biochemical indexes serum AFP and liver imaging liver ultrasound were collected before treatment baseline during treatment and after treatment The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks and the main evaluation indicators were the occurrence or reversal of cirrhosis complications hepatocellular carcinoma and mortality Secondary evaluation index the influence factors of different clinical outcomes To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors
Detailed Description:
This was a retrospective observational cohort study The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease Beijing Ditan Hospital Capital Medical University from October 2008 to April 2020 were enrolled Patients treated with antiviral drugs including interferon andor nucleoside acid analogues lasting more than 6 months were included in the study Interferon nucleoside acid analogue monotherapy combination therapy sequential therapy maintenance therapy and drug withdrawal therapy can all be included in the study HBV DNA content HBsAganti-HBs HBeAganti-HBe biochemical indexes serum AFP and liver imaging liver ultrasound were collected before treatment baseline during treatment and after treatment The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks and the main evaluation indicators were the occurrence or reversal of cirrhosis complications hepatocellular carcinoma and mortality Secondary evaluation index the influence factors of different clinical outcomes To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors
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