Clinical trial NCT04301882: An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C
Official title: An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of 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: 2020-03-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015).

Brief 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.

Detailed description: This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. Enrolled in the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, via interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ) For patients with chronic hepatitis C treated, collect baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment, and follow-up observations of patients enrolled every 3-6 months. Collect clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) 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.

Eligibility criteria: Inclusion Criteria:

* Ages 18 to 75;
* Unlimited gender;
* Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015)
* No hormones and / or immunosuppressants and other hepatoprotective drugs;
* Sign a written informed consent.

Exclusion Criteria:

* Combined with other hepatitis virus (HBV, HDV) infections;
* Immune liver disease;
* HIV infection;
* long-term alcohol and / or other liver damage drugs;
* mental illness;
* Evidence of liver tumor (liver cancer or AFP\> 100 ng / ml);
* Decompensated cirrhosis;
* Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up;
* There are hormones and / or immunosuppressants and other hepatoprotective drugs.

Primary outcomes:
measure: Incidence of liver cancer
timeFrame: 144 weeks after withdrawal
measure: Incidence of decompensated cirrhosis
timeFrame: 144 weeks after withdrawal
Secondary outcomes:
measure: Rate of sustained virological response or relapse
timeFrame: 144 weeks after withdrawal
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hepatology Division 2, Beijing Ditan Hospital
state: Beijing
Study officials:
References: