TAF Switch Study in Hepatitis B Monoinfection

June 28, 2017 updated by: Ho Bae, Asian Pacific Liver Center at Coalition of Inclusive Medicine

Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF

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) .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF.

The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • HIV Infection

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAF Arm
Tenofovir alafenamide fumarate 25mg, 1 tablet once daily for 24 weeks
Drug: Tenofovir alafenamide fumarate
Patients on TDF will be switched to TAF
Other Names:
  • TAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure renal function after switch to TAF
Time Frame: one year
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
Time Frame: one year
Bone density will also be measured to compare T score and Z score before and after switching to TAF
one year

Collaborators and Investigators

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

Sponsor

Asian Pacific Liver Center at Coalition of Inclusive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 22, 2016

Primary Completion (Actual)

June 21, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-US-320-4200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Yes

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.

Clinical Trials on Hepatitis B

Clinical Trials on Tenofovir alafenamide fumarate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe