An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04301882
• Other study ID #: DTXY023
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2020
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• interferon combined with ribavirin (PR) antiviral therapy
Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months)
• direct antiviral drugs (DAAs)
Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)

Locations

Country	Name	City	State
China	Department of Hepatology Division 2, 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	Incidence of liver cancer	Incidence of liver cancer after chronic hepatitis C antiviral treatment	144 weeks after withdrawal
Primary	Incidence of decompensated cirrhosis	Incidence of decompensated cirrhosis after chronic hepatitis C antiviral treatment	144 weeks after withdrawal
Secondary	Rate of sustained virological response or relapse	Rate of sustained virological response or relapse after antiviral treatment of chronic hepatitis C	144 weeks after withdrawal