Tokyo, June 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062030) titled 'Prediction and Assessment of Hepatitis B Virus Reactivation Risk Under Immunosuppressive Therapy' on June 23.

Study Type: Observational

Primary Sponsor: Institute - Kyoto University

Condition: Condition - HBV reactivation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to develop an artificial intelligence (AI)-based predictive model capable of distinguishing progression to true HBV reactivation from spontaneous viral clearance by training on longitudinal viral load trajectories and clinical outcomes of patients with HBV reactivation who did not receive antiviral therapy. This multicenter study will be conducted in collaboration with 18 institutions across Japan, including Kyoto University Hospital. The proposed model is expected to enable evidence-based decision-making regarding individualized monitoring strategies and the optimal timing of therapeutic intervention. Ultimately, this approach may help avoid unnecessary antiviral treatment while contributing to the prevention of severe hepatitis associated with HBV reactivation. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients with resolved HBV infection, defined as HBsAg-negative and anti-HBc and/or anti-HBs-positive, who showed seroconversion of serum HBV DNA from below the detection or quantification limit and were diagnosed with HBV reactivation. Key exclusion criteria - Cases of HBV infection/reactivation considered to be derived from the graft liver after living donor liver transplantation will be excluded. Target Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 23 Day Anticipated trial start date - 2026 Year 06 Month 23 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070981

Disclaimer: Curated by HT Syndication.