Advanced Liver FibrosisPhase 1FEGATO-01NCT05939947
A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis
A Phase 1 study testing ALE.F02 in people with Advanced Liver Fibrosis and Liver Cirrhosis, run by Alentis Therapeutics AG at 6 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Liver Fibrosis, Liver Cirrhosis
- What is being tested?
- ALE.F02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Apr 2023to 30 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Romania2 sites
ARENSIA Exploratory Medicine S.R.L.
Bucharest, 011665
ARENSIA Exploratory Medicine S.R.L. - Cluj-Napoca
Cluj-Napoca, 400006
Slovakia2 sites
Summit Clinical Research
Bratislava, 851 05
Summit Clinical Research
Malacky, 90122
United States1 site
American Research Corporation
San Antonio, Texas, 78215
About this study
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
The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.
- Conditions
- Advanced Liver Fibrosis, Liver Cirrhosis
- Being tested
- ALE.F02, Placebo
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALE.F02Drug
Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.
PlaceboDrug
Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| ALE.F02 | Experimental | 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. Receives: Drug: ALE.F02 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis using noncompartmental analysis.
Maximum Serum Concentration [Cmax]
Measured: Baseline to Day 14 and Day 29 to Day 72
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]
Measured: Baseline to Day 14 and Day 29 to Day 72
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]
Measured: Baseline to Day 14 and Day 29 to Day 72
Secondary outcomes (2)
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
Measured: Baseline to Day 72
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.
Measured: Baseline to Day 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Apr 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alentis Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Manenti, MD, Study director, Alentis Therapeutics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939947
- Sponsor's protocol ID
- ALE.F02.02
- Acronym
- FEGATO-01
- Status last verified
- Nov 2024
- First submitted
- 21 Jun 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05939947
- Acronym / sponsor ID
- FEGATO-01 / ALE.F02.02
- Conditions
- Advanced Liver Fibrosis, Liver Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Alentis Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ALE.F02 | Experimental | Drug: ALE.F02Patients will receive 3 doses of ALE.F02 administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive 3 doses of matching placebo administered once every second week as a continuous intravenous (IV) infusion to a total of 3 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALE.F02Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses. | Drug | ALE.F02 |
| PlaceboContinuous intravenous (IV) infusion administered once every second week to a total of 3 doses. | Drug | Placebo |
Primary outcome
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]
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]
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]
2 secondary outcomes
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
Pharmacodynamic (PD) profile of ALE.F02 in patients with advanced liver fibrosis and/or with mild cirrhosis.
Time frame: Baseline to Day 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Manenti, MD study director
Alentis Therapeutics AG
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALE.F02 in people with Advanced Liver Fibrosis and Liver Cirrhosis, run by Alentis Therapeutics AG at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Romania, Slovakia, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.