HBV Clinical Trial
— HBVOfficial title:
The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients
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 CHB patients who will switch to TAF and then follow for one year. Demographic, liver function tests, sugar profiles, lipid profiles, ASCVD risk score, body weight, body weight, body height, and waist circumference will be checked and recorded periodically. Investigators anticipated that body weight will change significantly after switching to TAF in both entecavir and TDF group and may associated with increased risk of cardiovascular risk.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age more than 20 years. 2. Chronic hepatitis B virus infection defined as presence of positive HBsAg more than 6 months. 3. TAF naïve. 4. Patients already receiving TDF or entecavir treatment, and the scheduled NUC treatment from enrolment being greater than one year. Exclusion Criteria: 1. Other etiology of chronic hepatitis. 2. Severe comorbid disorders. 3. 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. 4. Uncontrolled diabetes mellitus (HBA1c > 8.5%). 5. Current evidence or suspicious of malignancy. 6. eGFR <50 ml/min/1.73m2. 7. 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. 8. Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng-Kung University Hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1.Body weight changes after shifting to TAF treatment. | Collection Body weight data before and after treatment. | 48 weeks | |
Secondary | 2.Changes of lipid and sugar profiles before and after shifting to TAF treatment. | Collection lipid( include TG48 weeks. |
| |
Secondary | 3.Virologic responses following TAF treatment. | Collection Virologic data (e.g HBV DNA48 weeks. |
| |
Secondary | 4.Renal function after shifting to TAF treatment. | Collection Renal function(include Cr48 weeks. |
| |
Secondary | 5. ASCVD score changes before and after shifting to TAF treatment. | Collection ASCVD score before and after treatment. | 48 weeks. |
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