A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis (FEGATO-01)

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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Advanced Liver Fibrosis
• Intervention / Treatment: Drug: ALE.F02; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Daniela Schmitter, PhD; Phone Number: +41782366290; Email: daniela.schmitter@alentis.ch
• Study Contact Backup: Name: Markus Meyer, PhD; Phone Number: +41763379886; Email: markus.meyer@alentis.ch

Study Locations

• Germany
  • Munich, Germany, 81241
    • Recruiting
    • APEX GmbH
    • Contact: Gernot Klein, MD
• Romania
  • Bucharest, Romania, 011665
    • Recruiting
    • ARENSIA Exploratory Medicine S.R.L.
    • Contact: Carmen Georgeta Fierbinteanu-Braticevici, Prof.
  • Cluj-Napoca, Romania, 400006
    • Recruiting
    • ARENSIA Exploratory Medicine S.R.L. - Cluj-Napoca
    • Contact: Adriana Bintintan, Dr.
• Slovakia
  • Bratislava, Slovakia, 851 05
    • Recruiting
    • Summit Clinical Research
    • Contact: Viera Kupcova, Prof.
  • Malacky, Slovakia, 90122
    • Recruiting
    • Summit Clinical Research
    • Contact: Edita Kadlubiakova, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALE.F02; Patients will receive 3 doses of ALE.F02 administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses.	Drug: ALE.F02; Continuous intravenous (IV) infusion over 1 hour administered once every second week to a total of 3 doses.
Placebo Comparator: Placebo; Patients will receive 3 doses of matching placebo administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses.	Drug: Placebo; Continuous intravenous (IV) infusion over 1 hour administered once every second week to a total of 3 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.	Maximum Serum Concentration [Cmax]	Baseline to Day 14 and Day 29 to Day 72
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.	Time of Maximum Serum Concentration [Tmax]	Baseline to Day 14 and Day 29 to Day 72
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.	Area under the serum concentration versus time curve [AUC0-tau, AUC0-inf]	Baseline to Day 14 and Day 29 to Day 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.	Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0 criteria Incidence of Serious Adverse Events assessed by CTCAE v5.0 criteria	Baseline to Day 72
Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.	Relative change (%) of serum levels of PRO-C3 between baseline and the EOT. Relative change (%) of serum levels of tissue inhibitor of matrix metalloproteinase [TIMP1] between baseline and the EOT. Relative change (%) of serum levels of hyaluronic acid between baseline and the EOT. Relative change (%) of serum levels of procollagen III amino-terminal peptide [PIIINP] between baseline and the EOT.	Baseline to Day 72

Collaborators and Investigators

• Sponsor: Alentis Therapeutics AG
• Investigators: Study Director: Luigi Manenti, MD, Alentis Therapeutics AG

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ALE.F02.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No