MedDataX Logo

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

NCT ID: NCT05939947

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Liver Fibrosis Liver Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

ALE.F02

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALE.F02

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alentis Therapeutics AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luigi Manenti, MD

Role: STUDY_DIRECTOR

Alentis Therapeutics AG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

American Research Corporation

San Antonio, Texas, United States

Site Status

APEX GmbH

Munich, , Germany

Site Status

ARENSIA Exploratory Medicine S.R.L.

Bucharest, , Romania

Site Status

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

Cluj-Napoca, , Romania

Site Status

Summit Clinical Research

Bratislava, , Slovakia

Site Status

Summit Clinical Research

Malacky, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Germany Romania Slovakia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALE.F02.02

Identifier Type: -

Identifier Source: org_study_id