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TAF Switch Study in Hepatitis B Monoinfection

NCT ID: NCT02957994

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-22

Study Completion Date

2017-11-01

Brief Summary

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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

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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.

Conditions

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Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAF Arm

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

Group Type EXPERIMENTAL

Tenofovir alafenamide fumarate

Intervention Type DRUG

Patients on TDF will be switched to TAF

Interventions

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Tenofovir alafenamide fumarate

Patients on TDF will be switched to TAF

Intervention Type DRUG

Other Intervention Names

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TAF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asian Pacific Liver Center at Coalition of Inclusive Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ho Bae

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 30576085 (View on PubMed)

Other Identifiers

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IN-US-320-4200

Identifier Type: -

Identifier Source: org_study_id