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

NCT05939947 | Completed Phase 1 FDA Drug

• 1 other identifier: ALE.F02.02
• Study Type: interventional
• Target: 41
• Locations: 4 countries
• Sites: 6

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.

Conditions

Advanced Liver Fibrosis; Liver Cirrhosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

• Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.

  Baseline to Day 72

Study Arms (2)

ALE.F02

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ALE.F02 DRUG

Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.

ALE.F02

Placebo DRUG

Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alentis Therapeutics AG: lead

Study Sites (6)

American Research Corporation

San Antonio, Texas, 78215, United States

Location

APEX GmbH

Munich, 81241, Germany

Location

ARENSIA Exploratory Medicine S.R.L.

Bucharest, 011665, Romania

Location

ARENSIA Exploratory Medicine S.R.L. - Cluj-Napoca

Cluj-Napoca, 400006, Romania

Location

Summit Clinical Research

Bratislava, 851 05, Slovakia

Location

Summit Clinical Research

Malacky, 90122, Slovakia

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luigi Manenti, MD

  Alentis Therapeutics AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 11, 2023
• Study Start: April 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2); US (1); DE (1); RO (2)