Clinical trial NCT04301908: A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
Official title: The Observational Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis b
Keywords: Chronic hepatitis B
Interferon
Nucleoside (acid) analogs
HBV DNA
Hepatitis B surface antigen
Hepatocellular carcinoma
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. All patients with chronic hepatitis B and cirrhosis met the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death
timeFrame: 288 weeks after antiviral therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hepatology Division 2, Beijing Ditan Hospital
state: Beijing
Study officials:
References: