Entecavir to TAF Switch

NCT ID: NCT03489239

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2020-09-16

Brief Summary

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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

Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single Arm

SingleArm: TAF 25 mg

Group Type EXPERIMENTAL

Tenofovir Alafenamide

Intervention Type DRUG

subjects switching from Entecavir to single arm TAF 25mg

Interventions

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Tenofovir Alafenamide

subjects switching from Entecavir to single arm TAF 25mg

Intervention Type DRUG

Other Intervention Names

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TAF

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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11729

Identifier Type: -

Identifier Source: org_study_id

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