Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059333) titled 'A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy' on Oct. 8.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Chronic hepatitis B Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the longitudinal changes in HBV related markers among patients with chronic hepatitis B both those receiving nucleos(t)ide analogue (NA) therapy and those not receiving such treatment. Furthermore, to elucidate the clinical outcomes of these patients, including hepatocarcinogenesis, hepatic decompensation events, and death, as well as the factors associated with these outcomes. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with chronic hepatitis B who visited the participating institution after the date of approval by the head of the institution and who are either receiving nucleos(t)ide analogue (NA) therapy or not receiving NA therapy Individuals aged 18 years or older at the time of obtaining informed consent Individuals who have continued NA therapy for at least one year (NA treatment group) Individuals who have provided written informed consent to participate in the study Key exclusion criteria - Patients co-infected with HCV or HIV Patients with concomitant hepatocellular carcinoma (HCC) Patients within 3 months after treatment for HCC Patients receiving nucleos(t)ide analogues for the prevention of HBV reactivation Pregnant or lactating women Individuals deemed ineligible by the principal investigator or co-investigators for any other reason Target Size - 2500

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 01 Day Date of IRB - 2025 Year 09 Month 16 Day Anticipated trial start date - 2025 Year 09 Month 26 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066571

Disclaimer: Curated by HT Syndication.