NCT04071353

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Interferon	Interferon combined with ribavirin antiviral therapy
DRUG	ribavirin	Interferon combined with ribavirin antiviral therapy
DRUG	DAAs	DAAs antiviral treatment

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2019-08-28
• Last updated: 2019-08-28

Locations

1 site across 1 country: China