A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis

Sponsor

Beijing Ditan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04301908

Collaborator

(none)

10,000

Enrollment

Location

Anticipated Duration (Months)

833.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a retrospective observational cohort study. The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled. Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study. Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment. The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality. Secondary evaluation index: the influence factors of different clinical outcomes. To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	Drug: interferon

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Observational Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
antiviral therapy group Patients with chronic hepatitis B and cirrhosis were treated with antiviral drugs	Drug: interferon Antiviral therapy for patients with chronic hepatitis B and cirrhosis. Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study. Other Names: nucleoside (acid) analogues

Arm

Intervention/Treatment

antiviral therapy group

Patients with chronic hepatitis B and cirrhosis were treated with antiviral drugs

Drug: interferon

Antiviral therapy for patients with chronic hepatitis B and cirrhosis. Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study.

Other Names:

nucleoside (acid) analogues

Outcome Measures

Primary Outcome Measures

The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death [288 weeks after antiviral therapy]
The incidence or reversal of cirrhosis comorbidities, the incidence of liver cancer, and the incidence of death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages 18 to 75;
Unlimited gender;
Patients with chronic hepatitis B treated with interferon and / or nucleoside (acid) analogs (NA) antiviral therapy. All patients with chronic hepatitis B met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)
No hormones and / or immunosuppressants and other hepatoprotective drugs;
Sign a written informed consent.

Exclusion Criteria:

Combined with other hepatitis virus (HCV, 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.