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

Liver Cirrhosis Clinical Trial

— FEGATO-01  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939947
• Other study ID #: ALE.F02.02
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2024
• Source: Alentis Therapeutics AG
• Contact: Daniela Schmitter, PhD
• Phone: +41782366290
• Email: daniela.schmitter[@]alentis.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• ALE.F02
Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.
• Placebo
Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.

Locations

Country	Name	City	State
Germany	APEX GmbH	Munich
Romania	ARENSIA Exploratory Medicine S.R.L.	Bucharest
Romania	ARENSIA Exploratory Medicine S.R.L. - Cluj-Napoca	Cluj-Napoca
Slovakia	Summit Clinical Research	Bratislava
Slovakia	Summit Clinical Research	Malacky
United States	American Research Corporation	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alentis Therapeutics AG

Countries where clinical trial is conducted

United States,  Germany,  Romania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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