Entecavir to TAF Switch | NCT03489239

Studies
Entecavir to TAF Switch

NCT03489239

Sponsor

Thomas Jefferson University

Status

Active, not recruiting

Last Update Posted

Jun 25, 2020Actual

Enrollment

27Actual

Phase

Phase 3

Conditions

Hepatitis B

Interventions

Tenofovir Alafenamide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2017Actual

Primary Completion Date

Aug 15, 2020Estimated

Completion Date

Sep 16, 2020Estimated

First Submitted Date

Mar 14, 2018

First Submission Date that Met QC Criteria

Apr 3, 2018

First Posted Date

Apr 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2020

Last Update Posted Date

Jun 25, 2020Actual

Name	Class
Gilead Sciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	SingleArm: TAF 25 mg	Drug: Tenofovir Alafenamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tenofovir Alafenamide	Drug	subjects switching from Entecavir to single arm TAF 25mg	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	96 Weeks
Positive eGFR changes at study completion compared to Baseline visit

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University		Philadelphia	Pennsylvania	19107	United States

Submission Tracking

Estimated Results First Submitted Date

Oct 18, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 18, 2021			Nov 15, 2021	6
Dec 13, 2021

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C442442	tenofovir alafenamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided