Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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

Are you an adult living with advanced liver scarring (fibrosis) or early-stage liver disease (mild cirrhosis)? This study, called a Phase 1b trial, is looking for volunteers like you. We're testing a new potential medicine called ALE.F02 to understand how it works in the body and if it's safe. Half the participants will receive the active medicine, while the other half will get a placebo (a dummy treatment) – neither you nor your study doctor will know which you are receiving. This setup helps us fairly compare the effects of the new medicine. The main goal is to see how your body handles ALE.F02 and gather early information on whether it might be a helpful treatment for these liver conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Alentis Therapeutics AG

Enrolment target

Start

21 Oct 2024

Advanced liver fibrosis and/or mild liver cirrhosis

What is this study about?

This research study is focused on people who have significant scarring of the liver, often referred to as advanced liver fibrosis, or those with early signs of irreversible liver damage, known as mild cirrhosis. These conditions mean the liver isn't working as well as it should and can lead to serious health problems over time. Researchers are testing a new potential medicine called ALE.F02 to see if it could help.

The study is designed in a way that is common for testing new medicines. It's 'double-blind,' which means that neither you nor your study doctor will know if you're receiving the new medicine (ALE.F02) or a placebo (a treatment that looks exactly like the medicine but contains no active ingredients). This helps ensure the results are as fair and unbiased as possible. The study is also 'randomised,' meaning you'll be assigned to either the medicine or the placebo by chance.

This is an early-stage trial, referred to as Phase 1b. This phase mainly helps us learn how the body deals with the new medicine – how it's absorbed, distributed, broken down, and removed. It also looks for any early signs of whether the medicine is safe and if it has any effects on the body. This information is crucial for deciding if the medicine should be tested in larger studies in the future.

Key takeaways

This study tests a new medicine (ALE.F02) for advanced liver scarring or early cirrhosis.
It aims to understand how the body uses the medicine and check its safety.
Participants will receive either the new medicine or a dummy treatment randomly.
Neither you nor your doctor will know which treatment you are getting.
This is an early-stage study (Phase 1b) for research purposes.
You will be closely monitored by a medical team if you participate.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important health requirement for this study is that you must have either advanced liver fibrosis, which means your liver has a significant amount of scarring, or mild liver cirrhosis, which is an early stage of more permanent liver damage. Your doctors will be able to confirm if you meet these specific health conditions through your medical records and tests.

There might be other health conditions or medicines that would prevent you from taking part, to ensure your safety and the accuracy of the study results. These details would be discussed fully with you by the study team if you express interest.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with advanced liver fibrosis?
Or, have you been diagnosed with mild liver cirrhosis?
Are you able to attend regular clinic appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new medicine (ALE.F02) or a dummy treatment (placebo) for a set period. You would have regular visits to the study clinic, likely for check-ups, blood tests, and possibly other scans or assessments to monitor your liver health and how your body is reacting to the treatment. These visits help the study team understand how the medicine is working and to ensure your safety.

Throughout the study, you'll be carefully monitored by a medical team. Once the treatment period is over, there will be follow-up appointments to check on your health. The total time for your involvement in the study, including all treatments and follow-up, will be explained in detail by the study team, but typically, early phase studies involve several visits over a few months.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving a new investigational treatment that might help your liver condition, even if it's currently unproven. You'll also receive close medical attention and monitoring from a specialist team. However, there are potential risks, as any new medicine can have side effects, some of which may be unknown. There's also no guarantee that the new medicine will help you, or that you'll even receive the active medicine. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Slovakia
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Unverified
Romania

Common questions

What is liver fibrosis?

Liver fibrosis means your liver has developed scar tissue. It can happen after long-term damage or inflammation. If it gets severe, it can lead to cirrhosis.

What is mild cirrhosis?

Cirrhosis is when liver scarring becomes widespread and permanent, affecting how your liver works. 'Mild' means it's an early stage before it causes very serious problems.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know if you are getting the active medicine or a dummy treatment (placebo). This helps make the study results fair.

Will I definitely get the new medicine?

No, because it's a 'randomised' study, you have an equal chance of receiving either the active medicine (ALE.F02) or a placebo (dummy treatment).

What is a 'Phase 1b' study?

This is an early stage of human testing for a new medicine. It helps researchers understand how the medicine works in the body and if it's safe for people with the condition.