Back to resultsA Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis (FEGATO-01)
Primary Purpose
Advanced Liver Fibrosis, Liver Cirrhosis
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ALE.F02
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Advanced Liver Fibrosis
Eligibility Criteria
Principal Inclusion Criteria: Outpatients between 18 and 70 years Have been diagnosed with advanced liver fibrosis or mild cirrhosis attributable to NASH or following a sustained virological response to treatment for hepatitis C Have an ELF Score of at least 9.8 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 130.0 kg Clinical frailty score <7 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 Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, autoimmune disorders Is a woman of childbearing potential
Sites / Locations
- APEX GmbHRecruiting
- ARENSIA Exploratory Medicine S.R.L.Recruiting
- Summit Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALE.F02
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
Maximum Serum Concentration [Cmax]
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]
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]
Secondary Outcome Measures
Target engagement (TE) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
Relative change (%) of serum levels of CD44 between baseline and the EOT.
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0 criteria
Incidence of Serious Adverse Events assessed by CTCAE v5.0 criteria
Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05939947
Brief Title
A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis
Acronym
FEGATO-01
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alentis Therapeutics AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Liver Fibrosis, Liver Cirrhosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Thirty-four patients will receive 3 doses of ALE.F02 or matching placebo, administered once every second week as a continuous intravenous (IV) infusion over 1 hour, to a total of 3 doses per patient at the same dose level. The 3 cohorts are enrolled in a staggered sequence and escalated upon review and approval of a Safety Review Committee: Cohort 1 (low dose) (8:4 active:placebo), Cohort 2 (intermediate dose) (8:4), Cohort 3 (high dose) (8:2).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALE.F02
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
ALE.F02
Intervention Description
Continuous intravenous (IV) infusion over 1 hour administered once every second week to a total of 3 doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Continuous intravenous (IV) infusion over 1 hour administered once every second week to a total of 3 doses.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
Description
Maximum Serum Concentration [Cmax]
Time Frame
Baseline to Day 14 and Day 29 to Day 43
Title
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
Description
Time of Maximum Serum Concentration [Tmax]
Time Frame
Baseline to Day 14 and Day 29 to Day 43
Title
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
Description
Area under the serum concentration versus time curve [AUC0-tau, AUC0-inf]
Time Frame
Baseline to Day 14 and Day 29 to Day 43
Secondary Outcome Measure Information:
Title
Target engagement (TE) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
Description
Relative change (%) of serum levels of CD44 between baseline and the EOT.
Time Frame
Baseline to Day 72
Title
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
Description
Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0 criteria
Incidence of Serious Adverse Events assessed by CTCAE v5.0 criteria
Time Frame
Baseline to Day 72
Title
Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
Description
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.
Time Frame
Baseline to Day 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Principal Inclusion Criteria:
Outpatients between 18 and 70 years
Have been diagnosed with advanced liver fibrosis or mild cirrhosis attributable to NASH or following a sustained virological response to treatment for hepatitis C
Have an ELF Score of at least 9.8 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 130.0 kg
Clinical frailty score <7
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
Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, autoimmune disorders
Is a woman of childbearing potential
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Schmitter, PhD
Phone
+41782366290
Email
daniela.schmitter@alentis.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Meyer, PhD
Phone
+41763379886
Email
markus.meyer@alentis.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Manenti, MD
Organizational Affiliation
Alentis Therapeutics AG
Official's Role
Study Director
Facility Information:
Facility Name
APEX GmbH
City
Munich
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gernot Klein, MD
Facility Name
ARENSIA Exploratory Medicine S.R.L.
City
Bucharest
ZIP/Postal Code
011665
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Georgeta Fierbinteanu-Braticevici, Prof.
Facility Name
Summit Clinical Research
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viera Kupcova, Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis
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