Seladelpar 10 mg Capsule for Primary Biliary Cirrhosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Barts Health NHS Trust, London, United KingdomPrimary Biliary CirrhosisSeladelpar 10 mg Capsule - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for safety and effectiveness in treating primary biliary cholangitis, a chronic liver disease.

Eligible Conditions
  • Primary Biliary Cirrhosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: 60 Months

60 Months
Ascites
Change in MELD
Death
Hospitalization for hepatic encephalopathy
Hospitalization for spontaneous bacterial peritonitis
Hospitalization for variceal bleeding
Liver transplantation
Normalization of ALP
Response on composite endpoint
Month 60
Laboratory Value: Alanine Aminotransferase (ALT)
Laboratory Value: Aspartate Aminotransferase (AST)
Laboratory Value: Bilirubin - Conjugated Bilirubin
Laboratory Value: Bilirubin - Total Bilirubin
Laboratory Value: Bilirubin - Unconjugated Bilirubin
Laboratory Value: Gamma-glutamyl Transferase (GGT)
Laboratory Value: Serum Alkaline Phosphatase (ALP)
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

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

Seladelpar 5 mg Capsules
Drug
Experimental Group · 1 Intervention: Seladelpar 5 mg Capsule · Intervention Types: Drug
Seladelpar 10 mg Capsule
Drug
Experimental Group · 1 Intervention: Seladelpar 10 mg Capsule · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months

Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
2,414 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have previously taken part in a research study involving the drug seladelpar for primary biliary cholangitis (PBC).

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Pinnacle Clinical Research, PLLC100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.