Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02582333
Study type Observational
Source Taichung Veterans General Hospital
Contact
Status Completed
Phase
Start date October 1, 2015
Completion date March 13, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04101448 - Prevalence of Bronchiectasis in COPD Patients
Recruiting NCT03635619 - The Application of 3T MRI in Esophageal Cancer
Recruiting NCT04377854 - Prognostic Value of BNP in MCS - a 25 Year Follow up Study
Completed NCT05586828 - A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
Enrolling by invitation NCT04517981 - Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
Recruiting NCT05229328 - Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis
Completed NCT04470440 - Thyroid Dysfunction and Nivolumab Reponse in NSCLC
Recruiting NCT05848310 - Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
Completed NCT03652402 - Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
Recruiting NCT04651933 - A Training Set for the HRD Model in EOC
Completed NCT04651920 - A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
Recruiting NCT03843905 - Predictive Value of Innovative Prognostic Markers (Gut Microbiota, Sarcopenia, Metabolic Syndrome and Obesity) on Surgical and Oncologic Results in the Management of Sporadic Colorectal Adenocarcinoma.
Completed NCT05620537 - A Novel Nomogram to Predict the Postoperative Overall Survival in Gastrointestinal Cancer Patients
Recruiting NCT03738319 - Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer
Recruiting NCT03742869 - HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
Completed NCT03268096 - Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination
Recruiting NCT04004559 - MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)
Recruiting NCT05494502 - Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients N/A
Recruiting NCT04411563 - Epigenetic Tools as Prognostic Predictors in Covid19
Not yet recruiting NCT04984915 - The Usefulness of CaIMR in Patients With STEMI