Status:
UNKNOWN
The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury.
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
In Taiwan, non-cirrhosis CHB patients with mildly elevated ALT are not candidates for antiviral treatment under Taiwan NIH reimbursement criteria. Disease severity could range from mildly liver injury...
Detailed Description
1. INTRODUCTION 1.1. Overview Hepatitis B virus (HBV) infection could lead to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma (HCC). Liver diseases and its complications remains one o...
Eligibility Criteria
Inclusion
- Age more than 20 years
- Presence of HBsAg positivity for more than 6 months that indicated chronic HBV infection;
- HBV viral load more than 20000 IU/mL in HBeAg positive or more than 2000 IU/mL in HBeAg Negative CHB patients;
- Presence of liver injury which was defined as histology activity index (HAI) \>3 by Knodell necroinflammantion scoring system or liver fibrosis stage 2 or stage 3 by Metavir scoring system; Liver histology available for evaluation 6 months before starting screening is also acceptable. This criteria is limited to subjects enrolling TAF treatment group.
- ALT level between 1-2 folds of ULN for at least one occasion in recent 1 year before screening;
- Treatment naïve;
Exclusion
- Other etiology of chronic hepatitis; Those patients with spontaneous clearance of HCV defined as presence of anti-HCV antibody but undetectable of HCV RNA at least 3 months before enrollment and without history of anti-viral treatment could be included.
- Severe comorbid disorders;
- Uncontrolled diabetes mellitus (HBA1c \> 8.5%);
- Current evidence or suspicious of malignancy;
- Diagnosis of liver cirrhosis;
- eGFR \< or = 30 ml/min/1.73m2.
- Any one of following hematology or biochemical or clinical abnormalities:
- 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 :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04674423
Start Date
May 14 2020
End Date
December 31 2025
Last Update
December 22 2020
Active Locations (1)
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1
National Cheng-Kung University Hospital
Tainan, Taiwan, 704