Status:
UNKNOWN
Tenofovir Alafenamide in HBV Related Decompensated Liver
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Conditions:
HBV
Eligibility:
All Genders
20-100 years
Phase:
PHASE4
Brief Summary
TAF is a new prodrug of tenofovir, specifically designed to achieve higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the alrea...
Eligibility Criteria
Inclusion
- Male or non-pregnant female, age ≥20 years
- Chronic HBV infection with positive hepatitis B surface antigen (HBsAg) for at least 6 months at screening.
- Hepatic decompensation, defined as Child-Turcotte-Pugh (CTP) score ≥7, or the presence of portal hypertension related complications including ascites, hepatic encephalopathy (\<grade 2) at screening.
- HBV NUC treatment naïve or experienced (except prior TAF) for Arm A or currently under HBV NUC treatment (except TAF) with HBV DNA \< 20 IU/mL within 6 months prior screening for Arm B.
- Patients with either liver cirrhosis or non-cirrhosis (defined by histology, non-invasive assessments, or imaging/clinical based diagnosis).
- Estimated creatinine clearance ≥30 ml/min (using the Cockcroft-Gault method) at screening. (Note: multiply estimated rate by 0.85 for women).
- Willing and able to provide informed consent
- Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion
- Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
- Previous recipient of a solid organ (including liver), or bone marrow transplant.
- Severe or uncontrolled comorbidities determined by the Investigator.
- Currently ≥grade 2 hepatic encephalopathy, currently or history (within 60 days) of variceal bleeding, hepatorenal syndrome, refractory ascites or spontaneous bacterial peritonitis; cytopenia of absolute neutrophil count \< 750/mm3, or hemoglobin \< 8 g/dL, or platelet \<30000/mm3; or MELD score ≥30 at screening.
- Malignancy history including hepatocellular carcinoma, except basal cell skin cancer without recurrence for more than 5 years.
- Acute exacerbation of HBV, defined as an elevation of alanine aminotransferase (ALT) activity to more than 10 times the upper limit of normal and more than twice the baseline value.
- On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 16). Subjects on prohibited medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Screening.
- Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04683341
Start Date
September 1 2020
End Date
April 1 2025
Last Update
December 24 2020
Active Locations (1)
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1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 807