Active — Not RecruitingPhase 4

Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection

Taiwan52 participantsStarted 2021-06-22

Plain-language 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 chronic HBV infection. The aim of this prospective cohort study is to assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Estimated glomerular filtration rate

Timeframe: week 48

HBV viral load

Timeframe: week 48

Drug adherence score

Timeframe: week 48 (higher scores mean a better outcome)

Trial details

NCT IDNCT05410496

SponsorTaichung Veterans General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-30

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