Clinical trial NCT04071353: Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C
Official title: Observational Cohort Study of Clinical Outcomes After Antiviral Therapy in Chronic Hepatitis C Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis C
Keywords: chronic hepatitis C
Interferon
Ribavirin
Clinical outcome
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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). All patients with chronic hepatitis C were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of liver cancer
timeFrame: up to 144 weeks
measure: The incidence of decompensated cirrhosis
timeFrame: up to 144 weeks
Secondary outcomes:
measure: Percentage of persistent virological response or relapse
timeFrame: up to 144 weeks
measure: Related factors of liver cancer
timeFrame: up to 144 weeks
measure: Related factors of decompensated cirrhosis
timeFrame: up to 144 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: liver disease center, Beijing Ditan Hospital
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital
name: Yao Xie, phD/MD
role: STUDY_DIRECTOR
References: