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Completed

NCT Number: NCT05939947

A Clinical Trial 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

APEX GmbH, Munich, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALE.F02

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.

    Time frame: Baseline to Day 14 and Day 29 to Day 72

    Maximum Serum Concentration [Cmax]

  2. Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.

    Time frame: Baseline to Day 14 and Day 29 to Day 72

    Time of Maximum Serum Concentration [Tmax]

  3. Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.

    Time frame: Baseline to Day 14 and Day 29 to Day 72

    Area under the serum concentration versus time curve [AUC0-tau, AUC0-inf]

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.

    Time frame: 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alentis Therapeutics AG

Industry

Registry information

Official study 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

Acronym: FEGATO-01

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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