A pilot study of switching from multipe nucleos(t)ide analogues to tenofovir alafenamide fumarate monotherapy in patients with chronic hepatits B virus infectio

Phase 4

• Conditions: chronic hepatits B; HBV; D019694

• Registration Number: JPRN-jRCT1031220145
• Lead Sponsor: MOCHIDA Satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients with chronic HBV infection receiving multipe nucleot(s)ide analogues such as ETV plus TAF or LAM plus TAF

Exclusion Criteria

Patients who do not consent with clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral response rates at 4, 8, 12, 24 and 48 weeks, with the change to TAF monotherapy as week 0

Secondary Outcome Measures

Name	Time	Method
Changes of WBC, Hb, Plt, Alb, AST, ALT, ALP, LDH, GGT, Cre, BUN, eGFR, T-Chol, TG, Na, Cl, K, T-Bil, PT, M2BPGi, AFP, HBsAg, HBeAg, HBeAb, HBcrAg at 4, 8, 12, 24 and 48 weeks