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FXR Agonist

Seladelpar for Primary Biliary Cholangitis

Phase 3
Recruiting
Research Sponsored by CymaBay Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for individuals who have previously participated in a seladelpar study for Primary Biliary Cholangitis (PBC), are not pregnant or breastfeeding, and agree to use two forms of birth control. It's not open to those with certain liver conditions, kidney issues, cancer within the last 2 years, chronic viral hepatitis, or on specific medications affecting liver function.Check my eligibility
What is being tested?
The safety and tolerability of Seladelpar capsules at doses of 5 mg and 10 mg are being tested over a long term in subjects with PBC. This open-label study allows all participants to know which treatment they're receiving.See study design
What are the potential side effects?
While the specific side effects aren't listed here, common concerns may include gastrointestinal symptoms like nausea or diarrhea, potential liver-related issues such as jaundice or itching skin due to increased bilirubin levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using two forms of birth control during and 90 days after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
Secondary outcome measures
Ascites
Change in MELD
Death
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Seladelpar 5 mg CapsulesExperimental Treatment1 Intervention
Group II: Seladelpar 10 mg CapsuleExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
2,756 Total Patients Enrolled

Media Library

Seladelpar (FXR Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03301506 — Phase 3
Primary Biliary Cirrhosis Research Study Groups: Seladelpar 5 mg Capsules, Seladelpar 10 mg Capsule
Primary Biliary Cirrhosis Clinical Trial 2023: Seladelpar Highlights & Side Effects. Trial Name: NCT03301506 — Phase 3
Seladelpar (FXR Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03301506 — Phase 3
Primary Biliary Cirrhosis Patient Testimony for trial: Trial Name: NCT03301506 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Pinnacle Clinical Research, PLLC
California Pacific Medical Center- Sutter Pacific Medical Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I already answered this. I already answered thhis. I already answered this. I have been very lucky with two doctors and one medication.
PatientReceived 1 prior treatment
i am currently on a drug that works. it has worked for more than 10 years. when it stops working i'd like to know if something else is available. is there any payment for this study?
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Will parking be available?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
2017. "Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03301506.
All > Mississippi > Primary Biliary Cirrhosis
~42 spots leftby Dec 2024
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