EPICS-III
Help to bring hope to those suffering from PBC (Primary Biliary Cholangitis)
Do you have PBC? You may be a good fit for the clinical trial.
What Is PBC?
Primary biliary cholangitis (PBC), previously referred to as “primary biliary cirrhosis,” is a rare and progressive chronic liver disease, which can get worse over time, and mainly affects middle-aged women. PBC patients report itching and fatigue affecting the quality of life. If PBC disease is left untreated, patients may eventually progress to liver failure.
Why Participate?
The purpose of this research study is to test the effectiveness and safety of Saroglitazar Magnesium in subjects with PBC. If you have a liver disease called PBC and are interested in potentially participating in the EPICS-III study, please email or contact the Call Center to find a location near you.
How Does It Work?
If you agree to participate in this study, you will be required to undergo a screening process to determine your eligibility. You will be enrolled in the study only if the study doctor determines you to be eligible for the participation in this study. If found eligible, you will receive an active or placebo drug. Patients are HEROS, because of you, health care advancements are possible.
Find A Location
The EPICS-III study is being conducted across the United States. Find a location near you and see if you might be eligible to participate.
For an exact location and address, please contact the Call Center at
866-583-7427 or email [email protected]
FAQ
What is an Informed Consent Form?
An Informed Consent Form describes the purpose, procedures, possible benefits, and risks of the study. This document also, explains how your medical information will be used and who may see it.
You will review the Informed Consent Form with the study doctor or study staff. They can help explain words or information that you do not understand. Reading the form and talking to the study doctor or study staff may help you decide whether to take part or not. If you decide to take part in this study, you will sign your name at the end of the form and date it.
What is the SARO.21.001 (EPICS-III) clinical research study?
EPICS-III is a clinical study enrolling patients with diagnosed primary biliary cholangitis (PBC). This study has been planned to explore the treatment effect of Saroglitazar Magnesium in PBC. Therefore, Saroglitazar Magnesium 1 mg and 2 mg (tablet) doses are selected for this study to evaluate the effectiveness and safety of Saroglitazar Magnesium in patients with PBC.
What is Saroglitazar Magnesium?
Saroglitazar Magnesium is an investigational drug, which means it has not yet been approved by the United States (US) Food and Drug Administration (FDA) for any use. The purpose of this study is to help assess the safety and effective of Saroglitazar Magnesium in the treatment of PBC. Saroglitazar Magnesium is a once daily oral tablet that is thought to treat PBC by reducing both inflammation and bile levels in the liver.
What is a clinical study?
A clinical study, also known as a clinical trial, is designed to help assess the safety and effectiveness of an investigational drug for a specified condition.
Based on the results of the clinical study, regulatory authorities will decide if an investigational drug is safe and effective for use. If approved, the investigational drug will be made available for patients.
Do I have to pay to participate in the study?
You do not have to pay to participate. Rather, you may be compensated for your travel expenses for the duration of the study. Please talk to your clinical research study doctor for more information.
How long does the study take?
This study will take approximately 1 year with a total of 15 clinic visits.
Where is the nearest clinical research site near me?
To find if there is a clinical research site in a city by you, please click here. For an exact location and address, please contact the Call Center at 866-583-7427, or email us at [email protected]
Will I receive the study drug or placebo?
Patients who are selected will be assigned one of the three treatment groups (Saroglitazar Magnesium 1 mg, or Saroglitazar Magnesium 2 mg, or placebo).
Where can I go for more information about the study?
For more information on the study, please visit clinicaltrials.gov
Contact Us
Contact our Call Center to speak to one of our representatives:
866-583-7427
If you would like to send an email directly, write to us at [email protected]
Learn More
For more information on the study, please visit clinicaltrials.gov