Entecavir to TAF Switch

June 23, 2020 updated by: Thomas Jefferson University

Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
SingleArm: TAF 25 mg
Drug: Tenofovir Alafenamide
subjects switching from Entecavir to single arm TAF 25mg
Other Names:
  • TAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of viral Hepatitis B DNA to be <20 IU/mL
Time Frame: 48 weeks
The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete viral suppression at study completion
Time Frame: 96 Weeks
The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.
96 Weeks
Positive eGFR changes at study completion compared to Baseline visit
Time Frame: 96 weeks
Change in eGFR from baseline to Week 96
96 weeks
Improved Bone Mass Density at study completion
Time Frame: 96 weeks
% change from baseline in BMD at the hip and lumbar spine at Week 96.
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2017

Primary Completion (Anticipated)

August 15, 2020

Study Completion (Anticipated)

September 16, 2020

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11729

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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