NCT03489239

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

2.7 years

First QC Date

March 14, 2018

Last Update Submit

June 23, 2020

Conditions

Hepatitis B

Outcome Measures

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.

    48 weeks

Secondary Outcomes (3)

  • Complete viral suppression at study completion

    96 Weeks

  • Positive eGFR changes at study completion compared to Baseline visit

    96 weeks

  • Improved Bone Mass Density at study completion

    96 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

SingleArm: TAF 25 mg

Drug: Tenofovir Alafenamide

Interventions

Tenofovir AlafenamideDRUG

subjects switching from Entecavir to single arm TAF 25mg

Also known as: TAF
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

April 5, 2018

Study Start

November 16, 2017

Primary Completion

August 15, 2020

Study Completion

September 16, 2020

Last Updated

June 25, 2020

Record last verified: 2020-06

Locations

US(1)