A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis
This research study is looking into a new medicine called Saroglitazar Magnesium for a liver condition called Primary Biliary Cholangitis, or PBC. PBC is a long-term disease where the small bile ducts in the liver are slowly destroyed, which can affect how the liver works. The study aims to find out if this new medicine can improve liver test results, specifically certain levels in the blood, and if it's safe for people to use. To do this, some patients will receive the new medicine, while others will receive a 'placebo' – a dummy pill that looks the same but contains no active medicine. This allows researchers to compare the effects accurately. The study will last for a year, with various check-ups along the way.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication called Saroglitazar Magnesium for individuals living with Primary Biliary Cholangitis (PBC). PBC is a chronic liver disease that primarily affects women, where the small bile ducts in the liver gradually become damaged. This damage can cause bile to build up in the liver, leading to inflammation and scarring, and can significantly impact a person's quality of life.
The main goal of this study is to see if Saroglitazar Magnesium can improve important measures of liver health. Specifically, doctors will be looking at certain blood test results, like ALP and bilirubin, which are markers for liver function. They also want to understand if the medicine helps with symptoms like itching and how it affects overall well-being. By comparing the new medicine to a 'placebo' (an inactive dummy pill), researchers can determine if any changes are truly due to the new medicine.
This is a 'Phase 2b/3' study, which means it's a later stage of research. It's designed to gather more detailed information about how well the medicine works and its safety, building on earlier findings. The information learned from this study could help determine if Saroglitazar Magnesium could become a new treatment option for people with PBC, potentially offering a new way to manage the condition and improve health outcomes.
Key takeaways
- This study tests a new medicine for Primary Biliary Cholangitis (PBC).
- It aims to improve liver test results and check safety.
- Participants will receive either the new medicine or a dummy pill (placebo).
- The study lasts about one year with regular check-ups.
- Taking part could offer close medical monitoring and help others with PBC.
Who may be eligible?
To join this study, you must be an adult, aged 18 years or older. Both men and women are welcome to take part.
Beyond these basic requirements, there will be other specific medical criteria that your doctor will check to see if this study is suitable for you. These criteria are in place to ensure your safety and that the study results are as clear and accurate as possible. For example, your current health, other medicines you might be taking, and specific liver test results would all be considered.
It's important to remember that not everyone who meets the age and sex criteria will be able to join. Your doctor will discuss all the details with you to confirm if you're a good fit for this particular research study.
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?
- Do you have a diagnosis of Primary Biliary Cholangitis (PBC)?
- Are you able to attend regular clinic visits for about a year?
- Are you willing to potentially receive either the study drug or a placebo?
- Are you taking any other medications that your doctor would need to review?
What does participation involve?
If you decide to take part in this study, you would be involved for about a year. During this time, you would receive either the study medicine, Saroglitazar Magnesium, or a placebo (an inactive dummy pill). Neither you nor your study doctor would know which one you are taking – this is called a 'double-blind' study and helps ensure the results are unbiased.
You would have regular visits to the clinic, where the study team would check your health, take blood and urine samples, and ask you about how you are feeling. These tests include liver function tests to see how your liver is responding. You would also complete questionnaires about your quality of life and any itching you might experience, potentially at weeks 16, 24, and 52.
Your participation would involve taking the study tablets as instructed. The total duration of active treatment and follow-up would be 52 weeks, or about one year.
Potential risks and benefits
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Common questions
What is Primary Biliary Cholangitis (PBC)?
PBC is a long-term liver condition where the small tubes in your liver that carry bile become damaged, affecting how your liver works over time.
What is Saroglitazar Magnesium?
It's a new medicine being tested to see if it can improve liver health and function in people with PBC.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare against the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know until the study is over. This helps ensure fair results.
How long will the study last?
If you join, your participation in the study, including treatments and check-ups, will be for about one year (52 weeks).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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