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

ALE.F02.02

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

2023-04-01

2024-11-30

2024-11-30

Recruiting

Early phase I

38

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Thirty-eight patients will receive 3 doses of ALE.F02 or matching placebo, administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses per patient at the same dose level. The 4 cohorts are enrolled in a staggered sequence and escalated upon review and approval of a Safety Review Committee: Cohort 1 (low dose) (4:2 active:placebo), Cohort 2 (intermediate dose) (8:4), Cohort 3 (intermediate dose) (8:2), Cohort 4 (high dose) (8:2).', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double-blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 38, 'type': 'ESTIMATED'}}

2024-03-13