Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04301882
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2020-03-05
Brief Title:
An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C
Sponsor:
Beijing Ditan Hospital
Organization:
Beijing Ditan Hospital
Study Overview
Official Title:
An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
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 study is a two-way non-interventional long-term dynamic follow-up clinical observational cohort study In the Second Division of Liver Diseases Beijing Ditan Hospital Capital Medical University chronic hepatitis C patients who were treated with interferon combined with ribavirin PR antiviral therapy PR treatment for 6 months or more and or direct acting antivirals DAAs and the baseline antiviral treatment and discontinuation follow-up data of patients before antiviral treatment were collected and follow-up observations of patients were carried out for every 3-6 months The clinical data such as clinical biochemistry HCV RNA and serological indicators anti-HCV AFP and liver imaging liver ultrasound were collected during the study period The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index The aim is to explore long-term virological response and clinical outcomes and elucidate its influencing factors
Detailed Description:
This study is a two-way non-interventional long-term dynamic follow-up clinical observational cohort study Enrolled in the Second Division of Liver Diseases Beijing Ditan Hospital Capital Medical University via interferon combined with ribavirin PR antiviral therapy PR treatment for 6 months or more and or direct acting antivirals DAAs For patients with chronic hepatitis C treated collect baseline antiviral treatment and discontinuation follow-up data of patients before antiviral treatment and follow-up observations of patients enrolled every 3-6 months Collect clinical data such as clinical biochemistry HCV RNA and serological indicators anti-HCV AFP and liver imaging liver ultrasound during the study period The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index The aim is to explore long-term virological response and clinical outcomes and elucidate 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