A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis (FEGATO-01)

Alentis Therapeutics

Status and phase: Completed; Phase 1

Conditions: Liver Cirrhosis; Advanced Liver Fibrosis

Treatments: Drug: ALE.F02; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05939947

ALE.F02.02

Details and patient eligibility

About

The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.

Enrollment: 41 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

41 participants in 2 patient groups, including a placebo group

ALE.F02

Experimental group

Description:

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.

Treatment:

Drug: ALE.F02

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo