Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

Observational Cohort Study of Clinical Outcomes After Antiviral Therapy in Chronic Hepatitis C Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071353
• Other study ID #: DTXY021
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2019
• Source: Beijing Ditan Hospital
• Contact: Yao Xie, doctor
• Phone: 8613501093293
• Email: xieyao00120184[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up. Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months. Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period. At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.

Description:

This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up. Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months. Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period. At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic hepatitis C patients treated with interferon plus ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct antiviral drugs (DAAs)

Exclusion Criteria:

• Co-infected with hepatitis B virus or human immunodeficiency virus

• Had an autoimmune disease, liver tumour, or severe cardiac disease.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Interferon
Interferon combined with ribavirin antiviral therapy
• ribavirin
Interferon combined with ribavirin antiviral therapy
• DAAs
DAAs antiviral treatment

Locations

Country	Name	City	State
China	liver disease center, Beijing Ditan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of liver cancer	The incidence of liver cancer after anti-viral treatment of chronic hepatitis C	up to 144 weeks
Primary	The incidence of decompensated cirrhosis	The incidence of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C	up to 144 weeks
Secondary	Percentage of persistent virological response or relapse	Percentage of persistent virological response or relapse after antiviral therapy for chronic hepatitis C	up to 144 weeks
Secondary	Related factors of liver cancer	Related factors including viral indicators (HCV RNA content, anti-HCV), clinical biochemical indicators (ALT, AST, ALB, Tbil), blood routine and coagulation function indicators (PTA) and serum AFP and liver ultrasound results of liver cancer after anti-viral treatment of chronic hepatitis C	up to 144 weeks
Secondary	Related factors of decompensated cirrhosis	Related factors including viral indicators (HCV RNA content, anti-HCV), clinical biochemical indicators (ALT, AST, ALB, Tbil), blood routine and coagulation function indicators (PTA) and serum AFP and liver ultrasound results of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C	up to 144 weeks