Entecavir to TAF Switch

Hepatitis B Clinical Trial

Official title:

Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03489239
• Other study ID #: 11729
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 16, 2017
• Est. completion date: September 16, 2020

Study information

• Verified date: June 2020
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: September 16, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects, adult male and female =18 years of age with chronic hepatitis B with or without compensated cirrhosis

• Maintained on Entecavir for a minimum of 48 weeks

• Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.

• Estimated creatinine clearance = 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.

Exclusion Criteria:

• Subjects with known poor or non-compliance

• Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.

• Pregnant women and those who wish to become pregnant during the course of the study.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Drug:
• Tenofovir Alafenamide
subjects switching from Entecavir to single arm TAF 25mg

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of viral Hepatitis B DNA to be <20 IU/mL	The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.	48 weeks
Secondary	Complete viral suppression at study completion	The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.	96 Weeks
Secondary	Positive eGFR changes at study completion compared to Baseline visit	Change in eGFR from baseline to Week 96	96 weeks
Secondary	Improved Bone Mass Density at study completion	% change from baseline in BMD at the hip and lumbar spine at Week 96.	96 weeks