Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02582333 |
| Other study ID # |
CF15240B |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2015 |
| Est. completion date |
March 13, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Taichung Veterans General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
Importance:
To clinicians in treating chronic hepatitis B, this study will provide important data
regarding the clinical courses after stopping NA therapy, and important prognostic indicators
may be determined. These findings could help clinicians in decision making for
discontinuation of NA therapy and booking follow-up schedules. To basic scientists, this
study will provide the virological changes after stopping NA therapy, and these findings may
help developing further virological researches.
