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

NCT04030039 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 420

Last updated 2019-07-23

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Hepatitis B Infection

Interventions

DRUG

Interferon

chronic hepatitis B patients with interferon therapy

DRUG

nucleoside analogues

chronic hepatitis B patients with interferon therapy

Sponsors & Collaborators

  • Beijing Ditan Hospital

    lead OTHER

Principal Investigators

  • Yao Xie · Beijing Ditan Hospital, Beijing, China

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030039 on ClinicalTrials.gov