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TAF Switch Study in Hepatitis B Monoinfection

Primary Purpose

Hepatitis B

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Tenofovir alafenamide fumarate

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAF Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02957994

First Posted

October 24, 2016

Last Updated

June 28, 2017

Sponsor

Asian Pacific Liver Center at Coalition of Inclusive Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02957994

Brief Title

TAF Switch Study in Hepatitis B Monoinfection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 22, 2016 (Actual)

Primary Completion Date

June 21, 2017 (Actual)

Study Completion Date

November 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asian Pacific Liver Center at Coalition of Inclusive Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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) .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAF Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tenofovir alafenamide fumarate

Other Intervention Name(s)

TAF

Intervention Description

Patients on TDF will be switched to TAF

Primary Outcome Measure Information:

Title

measure renal function after switch to TAF

Description

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

Time Frame

one year

Title

measure bone density after switch to TAF

Description

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

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30576085

Citation

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.

Results Reference

derived

Learn more about this trial

TAF Switch Study in Hepatitis B Monoinfection

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