Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B

Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B - Effectiveness for switiching to tenofovir alafenamide

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031903

Enrollment

400

Registered

2018-03-26

Start date

2018-04-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with chronic hepatitis B and under treatment by nucleos(t)ide analogue(s) (lamivudine (LMV), adefovir dipivoxil (ADV), entecavir (ETV), and tenofovir disoproxil fumarate (TDF)), including compensated cirrhosis. 2.Patients with stable and well controlled hypertension, diabetes mellitus, heart diseases, CKD or risk of CKD (eGFR <60), and other patients whom Dr. consider appropriate to switch.

Exclusion criteria

Exclusion criteria: 1.Patients with decompensated cirrhosis 2.Patients with co-infection of hepatitis C virus 3.Patients with co-infection of human immunodeficiency virus 4.Patients with stable estimated glomerular filtration rate <15 mL/min/1.73 m2 5.Patients with albumin <30 g/L and platelets <30,000 6.Patients with autoimmune hepatitis 7.Constant heavy alcohol drinkers (converted to ethanol over 60 g/day) 8.Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding 9.Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons

Design outcomes

Primary

Measure	Time frame
Proportion of patients with virological response (HBV DNA level <2.1 log copies/mL) at weeks 24, 48, 96, 120 and 144 after switching from other nucleos(t)ide analogues to TAF	—

Secondary

Measure	Time frame
1.Changes from the baseline in hepatitis surface antigen levels 2.Changes from the baseline in serum alanine aminotransferase 3.Changes from the baseline in estimated glomerular filtration rate and urine beta-2 microglobulinuria 4.Changes from the baseline in albuminuria 5.Changes in spine-and hip-bone mineral density	—

Countries

Japan

Contacts

Public ContactEiichi Ogawa

Kyushu University Hospital Department of General Internal Medicine

e.ogawa.a65@m.kyushu-u.ac.jp092-642-5909

Outcome results