Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention

July 20, 2019 updated by: Yao Xie, Beijing Ditan Hospital

Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention

All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) CHB patients in the immunological control period, without any clinical treatment intervention; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV indicators and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.

Study Overview

Status

Unknown

Detailed Description

This study is a clinical observational cohort study. All chronic hepatitis B patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) chronic Hepatitis B patients in the immunological control period, without any clinical treatment intervention in this cohort; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy in this cohort; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment in this cohort; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment in this cohort; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment in this cohort; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment in this cohort. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV DNA loads, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.

Study Type

Observational

Enrollment (Anticipated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100015
        • Recruiting
        • liver disease center, Beijing Ditan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic hepatitis B patients with HBsAg < 100 IU/ml in an inactive carrying state were enrolled and treated with antiviral therapy (interferon and nucleoside analogs). All patients with chronic hepatitis B infection were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).

Description

Inclusion Criteria:

  • Inactive carrier status and chronic hepatitis B (CHB) patients with anti-viral therapy (interferon and nucleoside analogues) reaching HBsAg < 100 IU/ml.

Exclusion Criteria:

  • coinfection with other viruses including HCV, HDV, and HIV;
  • syphilis antibody positive;
  • co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease;
  • complication of cirrhosis or liver cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic hepatitis B patients during the immune control period
Patients with chronic HBV infection during the immune control period do not have any clinical treatment intervention cohort
Therapy group A
After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with interferon
chronic hepatitis B patients with interferon therapy
Therapy group B
After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they stopped to be treated with interferon
chronic hepatitis B patients with interferon therapy
Therapy group C
After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential nucleoside analogues
chronic hepatitis B patients with interferon therapy
chronic hepatitis B patients with interferon therapy
Therapy group D
After chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential interferon
chronic hepatitis B patients with interferon therapy
chronic hepatitis B patients with interferon therapy
Therapy group E
After chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with the nucleoside analogues
chronic hepatitis B patients with interferon therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts
Time Frame: 96 weeks
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV DNA re-yang rate during the 96-week study period in different observation cohorts
Time Frame: 96 weeks
HBV DNA re-yang rate and HBeAg re-yang rate during the 96-week study period in different observation cohorts
96 weeks
HBeAg re-yang rate during the 96-week study
Time Frame: 96 weeks
HBeAg re-yang rate during the 96-week study
96 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver cancer during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
liver cancer during the 96-week study period in different observation cohorts Incidence
96 weeks
Hepatitis episodes during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
Hepatitis episodes during the 96-week study period in different observation cohorts Incidence
96 weeks
cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence
96 weeks
its complications during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
its complications during the 96-week study period in different observation cohorts Incidence
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yao Xie, Beijing Ditan Hospital, Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

June 22, 2019

First Submitted That Met QC Criteria

July 20, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 20, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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