NCT02957994

Brief Summary

To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4

Status
unknown

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

First Submitted

Initial submission to the registry

October 24, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 22, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

October 24, 2016

Last Update Submit

June 28, 2017

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (2)

  • measure renal function after switch to TAF

    Kidney function will be measured by blood and urine to compare abnormal results before and after switching to TAF.

    one year

  • measure bone density after switch to TAF

    Bone density will also be measured to compare T score and Z score before and after switching to TAF

    one year

Study Arms (1)

TAF Arm

EXPERIMENTAL

Tenofovir alafenamide fumarate 25mg, 1 tablet once daily for 24 weeks

Drug: Tenofovir alafenamide fumarate

Interventions

Tenofovir alafenamide fumarateDRUG

Patients on TDF will be switched to TAF

Also known as: TAF
TAF Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive)
  • Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months
  • No prior nucleos(t)ide exposure prior to treatment with TDF
  • Treatment with TDF for a minimum of 12 months

You may not qualify if:

  • HIV Infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fong TL, Lee BT, Tien A, Chang M, Lim C, Ahn A, Bae HS. Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. J Viral Hepat. 2019 May;26(5):561-567. doi: 10.1111/jvh.13053. Epub 2019 Jan 16.

    PMID: 30576085DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 8, 2016

Study Start

December 22, 2016

Primary Completion

June 21, 2017

Study Completion

November 1, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share