Clinical trial NCT05939947: A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Liver Fibrosis
Liver Cirrhosis
Lead sponsor: Alentis Therapeutics AG
Sponsor class: INDUSTRY
First posted: 2023-07-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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).
Primary purpose: BASIC_SCIENCE

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


Eligibility 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 140.0 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

Primary outcomes:
measure: Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
timeFrame: Baseline to Day 14 and Day 29 to Day 72
measure: Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
timeFrame: Baseline to Day 14 and Day 29 to Day 72
measure: Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
timeFrame: Baseline to Day 14 and Day 29 to Day 72
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
timeFrame: Baseline to Day 72
measure: Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
timeFrame: Baseline to Day 72
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: Munich
country: Germany
facility: APEX GmbH
city: Bucharest
country: Romania
facility: ARENSIA Exploratory Medicine S.R.L.
city: Cluj-Napoca
country: Romania
facility: ARENSIA Exploratory Medicine S.R.L. - Cluj-Napoca
city: Bratislava
country: Slovakia
facility: Summit Clinical Research
city: Malacky
country: Slovakia
facility: Summit Clinical Research
Study officials:
affiliation: Alentis Therapeutics AG
name: Luigi Manenti, MD
role: STUDY_DIRECTOR
References: