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

JRCT ID: jRCT1031220145

Registered date:18/06/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: chronic hepatits B
• Date of first enrollment: 18/06/2022
• Target sample size: 20
• Study type: Interventional

Intervention(s)

First, sequencings for reverse transcriptase region of HBV pregenomic HBV-RNA are performed in patients with chronic hepatits B virus infection who are receiving multipe nucleot(s)ide analogues.
Secondly, the nucleos(t)ide analogues used for the treatment are switched from multipe nucleot(s)ide analogues to tenofovir alafenamide fumarate monotherapy in patietns without drug-resistant mutations in reverse transcriptase region.

Outcome(s)

• Primary Outcome: Viral response rates at 4, 8, 12, 24 and 48 weeks, with the change to TAF monotherapy as week 0
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with chronic HBV infection receiving multipe nucleot(s)ide analogues such as ETV plus TAF or LAM plus TAF
• Exclude criteria: Patients who do not consent with clinical trial

Related Information

• Primary Sponsor: MOCHIDA Satoshi