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

Phase 1

Completed

• Conditions: Advanced liver fibrosis and/or mild liver cirrhosis
• Interventions: Drug: ALE.F02; Drug: Placebo

• Registration Number: 2024-516455-40-00
• Lead Sponsor: Alentis Therapeutics AG

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-21
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: Ended
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ALE.F02	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.	Baseline to Day 14 and Day 29 to Day 72	Area under the serum concentration versus time curve \[AUC0-tau, AUC0-inf\]

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.	Baseline to Day 72	Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0 criteria; Incidence of Serious Adverse Events assessed by CTCAE v5.0 criteria
Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.	Baseline to Day 72	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.

Trial Locations

Locations (3)

Arensia Exploratory Medicine S.R.L.; 🇷🇴 Bucharest, Romania

Spitalul Clinic Judetean De Urgenta Cluj; 🇷🇴 Cluj-Napoca, Romania

Summit Clinical Research s.r.o.; 🇸🇰 Malacky, Slovakia

Arensia Exploratory Medicine S.R.L.

🇷🇴Bucharest, Romania

Carmen Georgeta Fierbinteanu-Braticevici

Site contact

+40721216720

georgeta.fierbinteanu.ext@arensia-em.com