Status:
ACTIVE_NOT_RECRUITING
Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients with Chronic HBV Infection
Lead Sponsor:
Taichung Veterans General Hospital
Collaborating Sponsors:
Institute of Adherence to Medication
Conditions:
Safety Issues
Chronic Hepatitis B
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with chronic hepatitis B (CHB), therefore TAF may be a good option in kidney or liver transplant patients with...
Detailed Description
Life-long nucleos(t)ide analogue (NA) therapy has been recommended in patients with chronic HBV infection after organ transplantation, therefore the safety of long-term NA therapy is particularly impo...
Eligibility Criteria
Inclusion
- At least 20 years of age
- Chronic HBV infection under NA therapy other than TAF
- Underwent kidney and/ or liver transplantation
- Without clinical or pathologic evidence of moderate or severe rejection
- Patients who are indicated for TAF switching therapy, such as concerns in virological response, biochemical response, drug compliance, or safety issues to other NAs.
Exclusion
- End stage renal disease (eGFR \< 15 mL/min/1.73m2)
- Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
- Any active malignancies
- Pregnant or breast-feeding women
- Known allergy to tenofovir-contained regimens
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05410496
Start Date
June 22 2021
End Date
July 30 2027
Last Update
January 9 2025
Active Locations (2)
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1
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 40705
2
China Medical University Hospital
Taichung, Taiwan, 40447