Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B
Not Applicable
Recruiting
- Conditions
- Chronic hepatitis B
- Registration Number
- JPRN-UMIN000031903
- Lead Sponsor
- Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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