NCT05939947

A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis

A Double-Blind Placebo-Controlled Randomised Phase 1b Study of the Pharmacokinetics of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Alentis Therapeutics AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.

Conditions

• Advanced Liver Fibrosis
• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	ALE.F02	Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.
DRUG	Placebo	Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2023-07-11
• Last updated: 2024-12-03

Locations

6 sites across 4 countries: United States, Germany, Romania, Slovakia

Regulatory

• FDA-regulated drug study