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Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy

NCT02582333 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 347

Last updated 2021-03-16

No results posted yet for this study

Summary

Background:

Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998, and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high viral load in a maximum duration of three years. However, there is a significant proportion of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current knowledge, in what conditions that the NA therapy can be successfully discontinued without hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and finding the prognostic indicators may be an important basis for stopping NA therapy in CHB patients in the future.

Objectives:

1. To access the clinical and virological changes after stopping NA therapy
2. To determine important prognostic indicators for stopping NA therapy

Methods:

In this prospective cohort study, the investigators plan to recruit CHB patients who are indicated for stopping NA therapy in the outpatient clinics according to the inclusion and exclusion criteria of this study, and clinical and virological data will be collected during routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed according the following data:

1. Patient characteristics: including age, sex, height, weight, waist circumference, history of alcohol drinking, antiviral therapy history, hepatitis history, and drug history.
2. Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis flare in the first 2 years after stopping NA therapy, liver function and virological status tests will be conducted for analysis.

Conditions

  • Virological Breakthrough
  • Prognosis

Interventions

OTHER

Observation for clinical and virological changes

Only observation after stopping nucleos(t)ide analogue

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Principal Investigators

  • Teng-Yu Lee, MD, PhD · Taichung Veterans General Hospital

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2020-10-01
Completion
2021-03-13

Countries

  • Taiwan

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 NCT02582333 on ClinicalTrials.gov