NCT03471624

Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment

Detailed description

Secondary Objective(s): 1. Describe persistence of ALT (alanine aminotransferase) normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment 2. To describe trends in serum creatinine and calculated creatinine clearance as available by local labs. 3. To describe trends in bone mass from baseline to 24 months after switch. https://med.stanford.edu/nguyenlab/clinical-trials.html

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide	Tenofovir alafenamide (TAF) is a new formulation of tenofovir with higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the already low risk of renal toxicity and bone loss with tenofovir disoproxil fumarate (TDF).

Timeline

• Start date: 2018-05-01
• Primary completion: 2022-04-19
• Completion: 2022-04-19
• First posted: 2018-03-20
• Last updated: 2023-11-18
• Results posted: 2023-07-03

Locations

12 sites across 4 countries: United States, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study