TAF Switch Study in Hepatitis B Monoinfection
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Drug: Tenofovir alafenamide fumarate||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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