CompletedPhase 1
A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis
Key facts
- Who runs it
- Alentis Therapeutics AG
- Where
- San Antonio, United StatesSee the siteAlso in 3 other countries, 5 sites
- Status
- Completed
- Phase
- Phase 1
- People taking part
- 41 people enrolled
- Started
- 1 Apr 2023
- Ended
- 30 Oct 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ALE.F02
- Placebo
- Record updated
- 3 December 2024
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Other 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
Where in United States
Also in 3 other countries, 5 sites
- American Research CorporationSan Antonio, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.
The 2 groups in the trial
- ALE.F02Treatment being tested
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.
- PlaceboPlacebo, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Record updated
- 3 December 2024