A Phase 2, Randomized, Controlled, Open Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy
This research is looking into a new treatment called VS-01 for adults who have a liver problem called hepatic encephalopathy (OHE). OHE can cause confusion and other symptoms because the liver isn't working properly. The study wants to find out if VS-01, given in two different ways alongside usual care, works better than usual care alone to improve these symptoms. We will also check how safe VS-01 is and how the body handles it. This is a "Phase 2" study, meaning it's an early stage of testing new treatments, focusing on finding the right dose and checking for side effects. Participants will be carefully monitored for any changes in their symptoms and overall health.
At a glance
What is this study about?
This study is for people who have a liver condition called overt hepatic encephalopathy (OHE), especially if their liver disease has recently worsened. OHE happens when your liver can't properly remove toxins from your blood, which can then affect your brain. This can lead to symptoms like confusion, forgetfulness, changes in personality, or difficulty with movement.
Researchers are testing a new treatment called VS-01. They want to see if adding VS-01 to the standard care you would normally receive helps to improve your OHE symptoms more effectively. The study will look at how quickly people's symptoms get better when they receive VS-01 compared to those who only receive standard care. "Improvement" means a reduction in the severity of your confusion or other symptoms.
It's important to understand that this is an early-stage study, known as "Phase 2." This means we are still learning a lot about VS-01. The main goals are to find out if VS-01 is safe, if it helps to improve OHE symptoms, and how it works in the body. By participating, you could help researchers understand if this new treatment could be a valuable option for people with OHE in the future.
Key takeaways
- Tests a new treatment (VS-01) for overt hepatic encephalopathy (OHE).
- Aims to see if VS-01 improves OHE symptoms faster than standard care.
- Compares two different ways of giving VS-01.
- This is an early-stage study (Phase 2) focused on safety and effectiveness.
- Participants will have regular check-ups and monitoring.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
You would be eligible if you have been diagnosed with overt hepatic encephalopathy (OHE) and your liver condition has recently worsened. This includes people whose liver disease has suddenly become more severe (called 'acute decompensation of liver cirrhosis') or a specific type of worsened liver failure (called 'acute-on-chronic liver failure grade 1').
There will be other specific health requirements that the study doctors will discuss with you to make sure the study is a good fit for your individual health situation and is safe for you to take part.
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 overt hepatic encephalopathy (OHE)?
- Has your liver condition recently worsened (acute decompensation or ACLF grade 1)?
- Are you able to attend regular hospital or clinic appointments for check-ups?
What does participation involve?
If you decide to take part in this study, you would receive either the new treatment, VS-01, along with standard care, or just standard care alone. The study is 'open-label,' which means both you and your study doctor will know which treatment you are receiving. The VS-01 treatment will be given in two different ways, or 'dwell times,' which the doctors will explain.
Throughout the study, you would have regular visits to the clinic for various assessments. These will include check-ups to see how your OHE symptoms are improving, blood tests to monitor your liver health and how your body is handling the medication, and other tests like ECGs (heart traces) to check your heart health. You will also be asked about any side effects you might experience.
The researchers will closely track how quickly your OHE symptoms get better. The total time you would be involved in the study, including follow-up appointments after your treatment, will be explained in detail by the study team.
Potential risks and benefits
Locations (4)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is overt hepatic encephalopathy (OHE)?
OHE is a serious condition where your liver can't properly clean your blood, causing toxins to build up and affect your brain, leading to symptoms like confusion.
What is VS-01?
VS-01 is the new treatment being tested in this study to see if it helps improve OHE symptoms.
Will I know if I'm getting the new treatment?
Yes, this is an 'open-label' study, meaning both you and your doctor will know if you are receiving VS-01 or standard care.
How long will the study last?
The study team will tell you the exact duration of your participation, including follow-up appointments, before you join.
What does a 'Phase 2' study mean?
Phase 2 means it's an early stage of testing, mainly focusing on finding the right dose, checking for safety, and seeing if the treatment works.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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