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

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ClinicalTrials.gov Identifier: NCT04301908
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

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
Chronic Hepatitis b Drug: interferon

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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Group/Cohort 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 Name: nucleoside (acid) analogues




Primary Outcome Measures :
  1. The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death [ Time Frame: 288 weeks after antiviral therapy ]
    The incidence or reversal of cirrhosis comorbidities, the incidence of liver cancer, and the incidence of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301908


Locations
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China, Beijing
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing, China, 100015
Sponsors and Collaborators
Beijing Ditan Hospital
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Responsible Party: Yao Xie, Director of Hepatology Division 2, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT04301908    
Other Study ID Numbers: DTXY024
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yao Xie, Beijing Ditan Hospital:
Chronic hepatitis B
Interferon
Nucleoside (acid) analogs
HBV DNA
Hepatitis B surface antigen
Hepatocellular carcinoma
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents