Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels — ATTACH  

Hepatitis B, Chronic Clinical Trial

Official title: A Multicenter, Open-label, Single Arm Trial for the Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels With a Comparison to Matched Historical Controls (ATTACH)

Status Recruiting

Clinical Trial Summary

Multicenter, Open-label, Single arm Trial with Matched Historical controls. Male and female adults with compensated liver cirrhosis due to chronic hepatitis B virus infection who have low-level viremia.

To assess the efficacy of Tenofovir Alafenamide (TAF) in reducing liver-related events (hepatocellular carcinoma, liver-related events and death, decompensated liver cirrhosis) in cirrhotic chronic hepatitis B patients with low-level viremia compared with matched historical controls.

Clinical Trial Description

This clinical trial is a multicenter, open label, single arm trial in cirrhotic chronic hepatitis B patients with low-level viremia beyond treatment indications by current guidelines.

A total of 200 subjects meeting eligibility criteria will be enrolled and assigned to Treatment Arm (A) and 200 subjects from matched historical cohort will be compared to Treatment Arm.

• Treatment Arm (A): 200 subjects, TAF 25mg once daily with food for 3 years

• Matched Historical Controls Arm (B): 200 subjects, patients who did not receive antiviral treatment during their follow-up period, and were matched with the treatment group in a 1:1 ratio according to their baseline characteristics by propensity-score matching method Treatment Arm is scheduled to be followed up to 3 years. The primary analysis set for efficacy analyses will be defined as all enrolled patients who received at least 1 dose of study medication (modified intention-to-treat analysis). Patients who discontinue the study drug prior to year 3 will be considered failures for all endpoints after the time of discontinuation.

Propensity scores will be computed using the following variables; age; sex; HBeAg positivity, HBV DNA level, ALT, platelet, albumin, total bilirubin, creatinine, prothrombin time, diabetes, hypertension, family history of HCC. Treatment arm will be matched to historical matched cohort by propensity score matching.

The primary endpoint will be analyzed with Kaplan-Meier methods and compared by the log-rank test between the two groups. Between-group comparisons of continuous or categorical baseline characteristics will be conducted using absolute standardized difference. Baseline factors predictive of virologic response will be also evaluated by univariate and multivariable analyses using logistic regression. All statistical analyses will be performed using and R (http://cran.r-project.org/). A P-value less than 0.05 will be considered statistically significant. ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

• NCT number: NCT04780204
• Study type: Interventional
• Source: Asan Medical Center
• Contact: Young-Suk Lim, PhD
• Phone: 82-2-3010-3190
• Email: limys@amc.seoul.kr
• Status: Recruiting
• Phase: Phase 4
• Start date: August 23, 2021
• Completion date: December 2026