A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
This research study is looking at new ways to treat a long-term liver condition called Primary Biliary Cholangitis (PBC). We're testing a combination of two existing medicines, OCALIVA and Bezafibrate, to see if they are safe and effective when used together. This study is specifically for people with PBC who haven't improved enough with their current treatment (Ursodeoxycholic Acid) or can't take it. We'll be carefully monitoring liver health markers to understand how well the new combinations work and if they cause any side effects. This is an important step in finding better treatment options for people living with PBC.
At a glance
What is this study about?
This study is investigating new treatment options for a chronic liver condition called Primary Biliary Cholangitis, or PBC. In PBC, the small bile ducts in the liver become damaged, leading to a build-up of harmful substances and eventually liver scarring. Over time, this can cause serious health problems. The main goal of this study is to see if combining two existing medications, OCALIVA (Obeticholic Acid) and Bezafibrate (also known as Bezalip), can be a more effective and safe way to manage PBC.
We know that some people with PBC don't respond well to the standard medication, Ursodeoxycholic Acid, or they might not be able to take it due to side effects. This study is designed specifically for those individuals, aiming to find better solutions. By combining these two drugs, researchers hope to see an improved effect on liver health markers, which could mean a better outlook for patients.
During the study, we will be carefully measuring various things in the blood, such as an enzyme called Alkaline Phosphatase (ALP) and others like GGT, ALT, and AST, which are indicators of liver function. We will also look at bile acids and cholesterol levels. By tracking these changes over 12 weeks, we can learn how well the new drug combinations are working and if they are safe for people to take.
Key takeaways
- This study explores new PBC treatment options for those not responding to current medicines.
- It combines two existing drugs, OCALIVA and Bezafibrate, to assess safety and effectiveness.
- Liver function markers will be closely monitored to track progress.
- Participation involves regular clinic visits and blood tests over at least 12 weeks.
- The goal is to find better ways to manage Primary Biliary Cholangitis.
Who may be eligible?
To join this study, participants must be at least 18 years old – there's no upper age limit. Both men and women can take part.
Specifically, the study is looking for people who have been diagnosed with Primary Biliary Cholangitis (PBC) and are currently taking a medication called Ursodeoxycholic Acid, but it hasn't been working well enough for them. This means their liver test results haven't improved as much as doctors would like, or they've had side effects that prevent them from taking it regularly.
There will be other medical checks to make sure the study is right and safe for you, and to ensure the results are clear. Your doctor will be able to review all the detailed criteria to confirm if you are suitable.
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 Primary Biliary Cholangitis (PBC)?
- Are you currently taking Ursodeoxycholic Acid for PBC, but it's not working well enough, or you can't tolerate it?
- Are you able to attend regular clinic appointments for blood tests and check-ups?
What does participation involve?
If you decide to take part in this study, you will be given study medication, which could be OCALIVA and Bezafibrate, or a placebo (a dummy pill with no active medicine) for one or both of these drugs. This is done to fairly compare the new treatments. You'll need to visit the study clinic regularly for check-ups, which will include blood tests to monitor your liver function and overall health. You'll also be asked about any side effects you might experience. The main part of the study where we look at the effects of the medicines will last for 12 weeks, but there might be follow-up visits or a longer treatment period afterwards. The total time you're involved in the study will be explained in detail by the study team.
Potential risks and benefits
Locations (12)
- —UnverifiedGermany
- —UnverifiedNorway
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedCroatia
- —UnverifiedCzechia
- —UnverifiedNetherlands
- —UnverifiedLithuania
- —UnverifiedFrance
- —UnverifiedEstonia
- —UnverifiedGreece
Common questions
What is Primary Biliary Cholangitis (PBC)?
PBC is a long-term liver disease where the small bile ducts in your liver are slowly damaged. This can affect how your liver works over time.
What does 'combination therapy' mean?
It means taking two different medications together to see if they work better than one alone, or better than existing treatments.
What are OCALIVA and Bezafibrate?
These are both medications that are already used to treat PBC or related conditions, but this study is looking at using them together in a new way.
What does a 'placebo' mean?
A placebo is a 'dummy' pill that looks like the study medication but contains no active drug. It helps researchers compare the real drug's effects accurately.
What are 'ALP' and 'GGT'?
These are enzymes found in your blood that signal how well your liver is functioning. Doctors often check these levels to monitor liver health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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