TAF Switch Study in Hepatitis B Monoinfection

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02957994
• Other study ID #: IN-US-320-4200
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 24, 2016
• Last updated: June 28, 2017
• Start date: December 22, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: June 2017
• Source: Asian Pacific Liver Center at St. Vincent Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: November 1, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Drug:
• Tenofovir alafenamide fumarate
Patients on TDF will be switched to TAF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asian Pacific Liver Center at St. Vincent Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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