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

• Status: Recruiting
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alentis Therapeutics AG

Criteria

Principal Inclusion Criteria:

• Outpatients between 18 and 80 years

• Have been diagnosed with advanced liver fibrosis or mild cirrhosis attributable to NASH, ALD, or following a sustained virological response to treatment for hepatitis C

• Have an ELF Score of at least 9.5 but no more than 13

• Have stable hepatic impairment, defined as no clinically significant change in disease status, and no previous liver cirrhosis decompensation episodes

• Body weight within the range of 50.0 kg to 130.0 kg

• Clinical frailty score <6

Principal Exclusion Criteria:

• Child-Pugh score ≥7, as determined at screening

• MELD score ≥12, as determined at screening

• Estimated glomerular filtration rate <60 mL/min per the CKD-EPI creatinine-cystatin C equation

• Current or history of HCC

• Be suffering from or have symptoms of an acute or chronic infection

• Have active hepatitis C infection

• Other causes of liver disease including, but not limited to, hepatitis B, autoimmune disorders drug-induced hepatotoxicity, Wilson's disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history review.

• Is a woman of childbearing potential