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Active, not recruitingNCT03489239Updated Jun 25, 2020

Entecavir to TAF Switch

A Phase 3 interventional study of Tenofovir Alafenamide in Hepatitis B, sponsored by Thomas Jefferson University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-25.

Sponsored by Thomas Jefferson University · Phase 3, Interventional, and Other

Phase
Phase 3
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Hepatitis B
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Single Arm

    SingleArm: TAF 25 mg

    Drug: Tenofovir Alafenamide

Interventions

  • DrugTenofovir Alafenamide

    subjects switching from Entecavir to single arm TAF 25mg

    Also known as: TAF

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 weeks

Secondary outcomes

  1. 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.

    Time frame: 96 Weeks

  2. Positive eGFR changes at study completion compared to Baseline visit

    Change in eGFR from baseline to Week 96

    Time frame: 96 weeks

  3. Improved Bone Mass Density at study completion

    % change from baseline in BMD at the hip and lumbar spine at Week 96.

    Time frame: 96 weeks

06

Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
07

Registry details

Key details

Study ID
NCT03489239
Lead sponsor
Thomas Jefferson University
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Apr 5, 2018
Start date
Nov 16, 2017
Primary completion
Aug 15, 2020 (estimated)
Completion
Sep 16, 2020 (estimated)
Last update
Jun 25, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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