Study Summary
This trial is testing a new drug for safety and effectiveness in treating primary biliary cholangitis, a chronic liver disease.
- Primary Biliary Cirrhosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 16 Secondary · Reporting Duration: 60 Months
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Seladelpar 5 mg Capsules
1 of 2
Seladelpar 10 mg Capsule
1 of 2
Experimental Treatment
500 Total Participants · 2 Treatment Groups
Primary Treatment: Seladelpar 10 mg Capsule · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Pinnacle Clinical Research, PLLC | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Frequently Asked Questions
For whom would this research be beneficial?
"This ongoing clinical trial has 500 open slots for patients that have biliary liver cirrhosis and are between 18-75 years old." - Anonymous Online Contributor
What other scientific studies have been done on Seladelpar 10 mg Capsule?
"Seladelpar 10 mg Capsule was first studied in the year 2017 at Soon Chun Hyang University Hospital Bucheon. So far, there have been 6 completed trials. At this moment in time, 3 trials are ongoing with a considerable number of these taking place in Toronto, Canada." - Anonymous Online Contributor
How many individuals are enrolled in this research project?
"In order to run this experiment, 500 patients that meet the inclusion criteria are needed. The sponsor, CymaBay Therapeutics, Inc., has chosen University Health Network in Toronto, Ontario and Toronto General Hospital in Richmond, Virginia as two of the many sites from which they will be conducting the trial." - Anonymous Online Contributor
Is this the first experiment of its kind?
"There are 3 ongoing studies involving Seladelpar 10 mg Capsule in 26 countries and 98 cities. The first study was conducted in 2017 by CymaBay Therapeutics, Inc. and completed Phase 3 drug approval with 500 patients. There have been a total of 6 studies since 2017." - Anonymous Online Contributor
Are researchers currently looking for new participants in this clinical trial?
"Yes, this is confirmed by the clinicaltrials.gov website which has the study listed as active and recruiting candidates. The trial was first posted on December 12th, 2017 with the most recent edit being October 10th, 2022." - Anonymous Online Contributor
What are the known risks of taking Seladelpar 10 mg Capsule?
"Seladelpar 10 mg Capsule is classified as a 3 on Power's safety scale. This means that there are multiple rounds of data supporting Seladelpar's efficacy and safety." - Anonymous Online Contributor
Is this study being conducted in more than one country within North America?
"Currently, this study has 34 patients. The University Health Network in Toronto, the Toronto General Hospital in Richmond, and the Richmond Community Hospital LLC., d/b/a Bon Secours Liver Institute of Richmond are a few of the locations where enrolment is still open." - Anonymous Online Contributor
Does this clinical trial have an age limit for participants?
"The age range that is eligible for this study starts at 18 and ends when the patient reaches 75 years old." - Anonymous Online Contributor