Entecavir to TAF Switch
Primary Purpose
Hepatitis B
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tenofovir Alafenamide
Sponsored by
About this trial
This is an interventional other trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
- Maintained on Entecavir for a minimum of 48 weeks
- Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
- Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.
Exclusion Criteria:
- Subjects with known poor or non-compliance
- Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
- Pregnant women and those who wish to become pregnant during the course of the study.
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
SingleArm: TAF 25 mg
Outcomes
Primary Outcome Measures
Results of viral Hepatitis B DNA to be <20 IU/mL
The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.
Secondary Outcome Measures
Complete viral suppression at study completion
The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.
Positive eGFR changes at study completion compared to Baseline visit
Change in eGFR from baseline to Week 96
Improved Bone Mass Density at study completion
% change from baseline in BMD at the hip and lumbar spine at Week 96.
Full Information
NCT ID
NCT03489239
First Posted
March 14, 2018
Last Updated
June 23, 2020
Sponsor
Thomas Jefferson University
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03489239
Brief Title
Entecavir to TAF Switch
Official Title
Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
August 15, 2020 (Anticipated)
Study Completion Date
September 16, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
SingleArm: TAF 25 mg
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide
Other Intervention Name(s)
TAF
Intervention Description
subjects switching from Entecavir to single arm TAF 25mg
Primary Outcome Measure Information:
Title
Results of viral Hepatitis B DNA to be <20 IU/mL
Description
The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Complete viral suppression at study completion
Description
The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.
Time Frame
96 Weeks
Title
Positive eGFR changes at study completion compared to Baseline visit
Description
Change in eGFR from baseline to Week 96
Time Frame
96 weeks
Title
Improved Bone Mass Density at study completion
Description
% change from baseline in BMD at the hip and lumbar spine at Week 96.
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
Maintained on Entecavir for a minimum of 48 weeks
Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.
Exclusion Criteria:
Subjects with known poor or non-compliance
Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
Pregnant women and those who wish to become pregnant during the course of the study.
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
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Entecavir to TAF Switch
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