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ALE.F02 for Liver Fibrosis (FEGATO-01 Trial)

Phase 1

Recruiting

Research Sponsored by Alentis Therapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with advanced liver fibrosis or mild cirrhosis attributable to NASH, ALD, or following a sustained virological response to treatment for hepatitis C

Clinical frailty score <6

Must not have

Current or history of HCC

Suffering from or having symptoms of an acute or chronic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 14 and day 29 to day 72

Summary

This trial aims to understand how the body processes ALE.F02 in patients with liver problems.

Who is the study for?

This trial is for outpatients aged 18-70 with advanced liver fibrosis or mild cirrhosis due to NASH or treated hepatitis C. Participants must be relatively fit (frailty score <7), have a specific ELF Score range, stable liver function without past decompensation, and weigh between 50-130 kg.

What is being tested?

The study tests ALE.F02 against a placebo in patients with impaired liver function. It aims to understand how the body processes ALE.F02 by examining its pharmacokinetics profile in these individuals.

What are the potential side effects?

While not specified here, potential side effects of ALE.F02 may include reactions at the injection site, gastrointestinal issues, fatigue, allergic responses, and changes in liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver damage is due to NASH, ALD, or treated hepatitis C.

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I am not considered frail according to a clinical assessment.

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I am between 18 and 80 years old.

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My liver condition is stable with no worsening or previous serious episodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had liver cancer.

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I am currently experiencing symptoms of an infection.

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I am currently infected with hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 14 and day 29 to day 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 14 and day 29 to day 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 14 and day 29 to day 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALE.F02Experimental Treatment1 Intervention

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 II: PlaceboPlacebo Group1 Intervention

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.

0 / 7Eligibility criteria met