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TAF Switch Study in Hepatitis B Monoinfection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02957994
Recruitment Status : Unknown
Verified June 2017 by Ho Bae, Asian Pacific Liver Center at St. Vincent Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : June 29, 2017
Information provided by (Responsible Party):
Ho Bae, Asian Pacific Liver Center at St. Vincent Medical Center

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) .

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Tenofovir alafenamide fumarate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 22, 2016
Actual Primary Completion Date : June 21, 2017
Estimated Study Completion Date : November 1, 2017

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 Name: TAF

Primary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ho Bae, Medical Director, Asian Pacific Liver Center at St. Vincent Medical Center Identifier: NCT02957994    
Other Study ID Numbers: IN-US-320-4200
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents