Primary Biliary Cholangitis with incomplete response or intolerant to ursodeoxycholic acid? Participate in a clinical trial

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"Help us evaluate if a new investigational drug is safe and effective in the treatment of PBC"
Age: 18 to 75 years old
Gender:
Any
Healthy Volunteers: No
Keywords: PBC, Primary Biliary Cholangitis, Seladelpar
Type: Drug study, Phase 3
Investigator:
Description
We invite you to take part in a research study because you have primary biliary cholangitis (PBC) and you are not responding well enough to or can't tolerate ursodeoxycholic acid. You must have been taking a stable dose of ursodeoxycholic acid (UDCA) for the past twelve months, OR you're not able to tolerate UDCA due to side effects.

This study will test the safety and efficacy of an investigational medicine called seladelpar. Previous research has shown that seladelpar may help treating the signs and symptoms of PBC, lower your alkaline phosphatase level, and decrease itching.

Primary Biliary Cholangitis (PBC) is a autoimmune chronic liver disease that destroys the bile ducts within the liver.

You will receive all study medication and study evaluations at no cost, and compensation for your time may be available.
This study requires

There will be a total of approximately 13 study visits over a period of approximately 60 weeks (about 1 year and 2 months).

If you qualify to participate in this study, you will be randomized (by chance, like a flip of a coin) to one of three treatment groups. You will have a 2 in 3 chance of receiving the study drug and a 1 in 3 chance of receiving placebo.

Open Label Study: At the end of this study all study participants can rollover to the open label study. This means that all participants will receive the study drug, seladelpar. The open label study will have visits every 3 months and will last up to 3 years.

Who can participate
  • 18 to 75 years old
  • Male or female with a diagnosis of PBC
  • On a stable and recommended dose of UDCA for the past twelve months OR be intolerant to UDCA
Compensation
You will receive $65 for each study visit completed. If you discontinue early from the study, you will receive a partial amount based on how many study visits you completed.

Travel reimbursement: There can be travel reimbursement on case by case basis which include airfare, car mileage and other cost related to travel.
Resources
Schedule
Study duration and period
Approximately 13 visits to the centerover a period of approximately 60 weeks
Location
UC Davis Medical Center
2000 Stockton Boulevard
Suite 100
Sacramento, CA 95817
Contact
Sandeep Dhaliwal
Research Topic
Conditions:
  • Primary Biliary Cholangitis

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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