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

NCT04301908 | Unknown

• 1 other identifier: DTXY024
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis b

Keywords

Chronic hepatitis B; Interferon; Nucleoside (acid) analogs; HBV DNA; Hepatitis B surface antigen; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death

  The incidence or reversal of cirrhosis comorbidities, the incidence of liver cancer, and the incidence of death

  288 weeks after antiviral therapy

Study Arms (1)

antiviral therapy group

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

Drug: interferon

Interventions

interferon DRUG

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.

Also known as: nucleoside (acid) analogues

antiviral therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Department of Hepatology Division 2, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Heartburn; Hepatitis B; Carcinoma, Hepatocellular

Interventions

Interferons; Nucleosides; Acids

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides; Inorganic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatology Division 2

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)