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An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C - Trial NCT04301882

Access comprehensive clinical trial information for NCT04301882 through Pure Global AI's free database. This phase not specified trial is sponsored by Beijing Ditan Hospital and is currently status unknown. The study focuses on Chronic Hepatitis C. Target enrollment is 1000 participants.

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NCT04301882
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Trial Details
ClinicalTrials.gov โ€ข NCT04301882
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An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C
An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients

Study Focus

Chronic Hepatitis C

interferon combined with ribavirin (PR) antiviral therapy

Observational

drug

Sponsor & Location

Beijing Ditan Hospital

Beijing, China

Timeline & Enrollment

N/A

Sep 01, 2019

Sep 01, 2020

1000 participants

Primary Outcome

Incidence of liver cancer,Incidence of decompensated cirrhosis

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.

ICD-10 Classifications

Chronic viral hepatitis C
Acute hepatitis C
Chronic viral hepatitis
Other chronic viral hepatitis
Chronic hepatitis, unspecified

Data Source

ClinicalTrials.gov

NCT04301882

Non-Device Trial