Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance
Real-life Data of Switching From Tenofovir Disoproxi Fumarate (TDF) to Tenofovir Alafenamide (TAF) in Virologically Suppressed Chronic Hepatitis B Patients With Antiviral Resistance
1 other identifier
observational
300
0 countries
N/A
Brief Summary
- To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral resistance, as determined by the proportion of virologically suppressed patients at week 48
- To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedJune 21, 2018
June 1, 2018
12 months
May 22, 2018
June 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum HBV DNA level
The proportion of subjects who achieve a sustained serum HBV DNA level \< 20 IU/mL (undetectable serum HBV DNA by PCR)
at week 48
Secondary Outcomes (4)
Serum HBV DNA level
at week 96
Hip and spine BMD
at 48, 96 week
Serum eGFR
at 24, 48, 72, and 96 week
Serum creatinine & PO4 level
at 24, 48, 72, and 96 week
Study Arms (2)
Tenofovir Disoproxil Fumarate 300 mg QD
Administered Tenofovir Disoproxil Fumarate 300 mg QD
Tenofovir Alafenamide
Administered Tenofovir Alafenamide 25 mg QD
Interventions
Administered Tenofovir disoproxil fumarate 300 mg QD
Administered Tenofovir Alafenamide 25 mg QD
Eligibility Criteria
The investigators will conduct a multicenter observational study to evaluate the safety and efficacy of TAF 25 mg QD in chronic hepatitis B patients with antiviral resistance who switch from TDF to TAF. Subjects will be obtained from an existing cohort of patients treated with a TDF-based regimen due to antiviral resistance, which has been supported by Gilead (IN-US-174-1255).
You may qualify if:
- Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- Adult male and non-pregnant, non-lactating female subjects, ≥20 years of age based on the date of the screening visit.
- Documented evidence of chronic HBV infection previously
- TDF monotherapy, TDF-based combination therapy, or switching to TAF at least 4 weeks prior to screening in virologically suppressed chronic hepatitis B patients with multi-antiviral resistance
- Must be willing and able to comply with all study requirements
You may not qualify if:
- Co-infection with HCV, HDV, HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 21, 2018
Study Start
September 1, 2018
Primary Completion
August 31, 2019
Study Completion
August 31, 2020
Last Updated
June 21, 2018
Record last verified: 2018-06