Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
- Registration Number
- NCT03471624
- Lead Sponsor
- Stanford University
- Brief Summary
Primary Objective:
To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment
- Detailed Description
Secondary Objective(s):
1. Describe persistence of ALT (alanine aminotransferase) normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment
2. To describe trends in serum creatinine and calculated creatinine clearance as available by local labs.
3. To describe trends in bone mass from baseline to 24 months after switch.
https://med.stanford.edu/nguyenlab/clinical-trials.html
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tenofovir Alafenamide for 24 months Tenofovir Alafenamide Participants on any antiviral treatment for chronic HBV who plan to be switched by their physician to be treated with TAF 25 mg for 24 months.
- Primary Outcome Measures
Name Time Method Number of Participants With HBV DNA <20 IU Per mL Baseline, 6, 12, 18, 24 months To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment.
- Secondary Outcome Measures
Name Time Method Number of Participants With Normal Alanine Aminotransferase (ALT). Baseline, 6, 12, 18, 24 months Alanine aminotransferase (ALT) normalization is defined if ALT was less than 35 U/L for men or 25 U/L for women
The Mean Bone Mass Density (T-score) Change Baseline, month 24 To describe trends in bone mass density from baseline to end of study. Bone Mass Density(BMD) was evaluated using T-score of Lumber-spine. The T-score is a comparison of the results to a average peak bone mass of healthy young adult. 0 indicates healthy young adult's mean with a SD of 1. Normal BMD was defined with T-score of -1.0 or above; osteopenia with T-score between -1.1 and -2.4, and osteoporosis with T-score of -2.5 or below (ref). Worsened BMD was defined by upstaging of BMD class from normal to osteopenia or worse or from osteopenia to osteoporosis. Improved BMD was defined by downstaging of BMD class from osteopenia to normal or osteoporosis to osteopenia or normal.
Calculated eGFR Baseline, 6, 12, 18, 24 months To describe trends in calculated eGFR as available by local labs. Estimated glomerular filtration rates (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) equation (eGFR \[mL∕min∕1.73m2\] =141 × \[minimum Scr∕K, 1\]α × \[maximum Scr/K, 1\]1.209 × 0.993age × 1.018 \[if female\] × 1.159 \[if black\]) where Scr is serum creatinine in µmol/L, K is 61.9 for females and 79.6 for males, α is -0.329 for females and -0.411 for males
Trial Locations
- Locations (12)
Saga University Hospital
🇯🇵Saga, Japan
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Osaka City University
🇯🇵Osaka, Japan
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
San Jose Gastroenterology
🇺🇸San Jose, California, United States
Nagoya City University
🇯🇵Nagoya, Japan
E-Da Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Nowon Eulji Medical Center, Eulji University College of Medicine,
🇰🇷Seoul, Korea, Republic of
Sanggye Paik Hospital, Inje University College of Medicine
🇰🇷Seoul, Korea, Republic of