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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04071353
Enrollment
1000
Registered
2019-08-28
Start date
2019-08-01
Completion date
2020-08-01
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

chronic hepatitis C, Interferon, Ribavirin, Clinical outcome

Brief 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.

Interventions

Interferon combined with ribavirin antiviral therapy

DRUGribavirin

Interferon combined with ribavirin antiviral therapy

DRUGDAAs

DAAs antiviral treatment

Sponsors

Beijing Ditan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of liver cancerup to 144 weeksThe incidence of liver cancer after anti-viral treatment of chronic hepatitis C
The incidence of decompensated cirrhosisup to 144 weeksThe incidence of decompensated cirrhosis after anti-viral treatment of chronic hepatitis C

Secondary

MeasureTime frameDescription
Percentage of persistent virological response or relapseup to 144 weeksPercentage of persistent virological response or relapse after antiviral therapy for chronic hepatitis C
Related factors of liver cancerup to 144 weeksRelated 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
Related factors of decompensated cirrhosisup to 144 weeksRelated 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

Countries

China

Contacts

Primary ContactYao Xie, doctor
xieyao00120184@sina.com8613501093293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026