F573 for Injection for the Treatment of Liver Injury/Failure

Acute-On-Chronic Liver Failure Clinical Trial

Official title: F573 for Injection for the Treatment of Liver Injury/Failure : Randomized, Double-blind, Placebo-controlled Phase Ⅱa Clinical Trial

Status Recruiting

Clinical Trial Summary

This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .

The primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), etc.).

Clinical Trial Description

In a randomized, double-blind, placebo-controlled design, the study was divided into two phases according to the subjects' risk of liver failure due to liver injury.

The first stage: Twenty-five patients with liver injury (DILI patients and other types of patients with the same degree of liver injury) were enrolled. The trial was first conducted in 16 participants, who were treated with 0.5,1.0,2.0 mg/kg of the experimental drug or placebo in a 1:1:1:1 ratio. Then, 9 patients with CHB were treated with the experimental drug, and the dose was determined according to the efficacy and safety test results of the 16 patients enrolled first.

The second stage:Twenty-four patients with liver injury (DILI patients and other patients with the same degree of liver injury) were enrolled, and eligible subjects were treated with the experimental drug or placebo in a ratio of 3:1, once a day for 14 days. The dosage was determined based on the results of phase I efficacy and safety trials.

After obtaining subject consent, pharmacokinetic blood samples will be collected for 9 CHB patients and all CHB patients in Phase 2.

The Third stage:

The study was randomized, double-blind, placebo-controlled. The study was divided into a screening period (14 days), treatment period (28 days), and follow-up period (90 days).

Eligible subjects received the trial drug or placebo at a ratio of 3:1 once a day, even Continued administration for 28 days, the dose was comprehensively considered according to the efficacy and safety test results of the first and second phases Yes. Subjects also received the drug acetyl cysteine injection (NAC). After stopping the medication, Participants were followed for 90 days for safety. During the study, subjects will be visited at planned sites Clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram examination, and abdominal B were performed Ultrasound, cardiac color ultrasound, biomarker detection, MELD score, AARC score, survival status assessment, AE was also monitored and concomitant/concomitant medication was recorded. ;

Related Conditions & MeSH terms

• Acute Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

• NCT number: NCT05689645
• Study type: Interventional
• Source: Beijing Continent Pharmaceutical Co, Ltd.
• Contact: ling zhang, Dr
• Phone: 13501209210
• Email: zhangling@bjcontinent.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 24, 2023
• Completion date: March 31, 2026