Status:
UNKNOWN
The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients.
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
HBV
Eligibility:
All Genders
20-80 years
Brief Summary
The aim of this study is to compare the BW and metabolic profiles of CHB patient before and after shifting to TAF therapy. In this study, investigators will enroll 100 entecavir and 100 TDF treated C...
Detailed Description
Currently, three oral nucleoside/tides analogues (NUC), including entecavir(ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), are available as the first line of treatment opt...
Eligibility Criteria
Inclusion
- Age more than 20 years.
- Chronic hepatitis B virus infection defined as presence of positive HBsAg more than 6 months.
- TAF naïve.
- Patients already receiving TDF or entecavir treatment, and the scheduled NUC treatment from enrolment being greater than one year.
Exclusion
- Other etiology of chronic hepatitis.
- Severe comorbid disorders.
- Patients with History of acute coronary syndrome, myocardial infarction, stable angina, coronary/other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease from atherosclerosis.
- Uncontrolled diabetes mellitus (HBA1c \> 8.5%).
- Current evidence or suspicious of malignancy.
- eGFR \<50 ml/min/1.73m2.
- Any one of following hematology or biochemical or clinical abnormalities indicating the presence of liver decompensation: Albumin \<3.5g/dL, Total Bilirubin \>2.5mg/dL, prothrombin time prolongation \>4 sec or INR \>1.7, platelet count \<100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.
- Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04886336
Start Date
June 4 2020
End Date
December 31 2022
Last Update
May 14 2021
Active Locations (1)
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1
National Cheng-Kung University Hospital
Tainan, Taiwan, 704