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Seladelpar 5 mg for Primary Biliary Cirrhosis

Phase 3
Waitlist Available
Research Sponsored by CymaBay Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial looks at whether seladelpar can improve cholestasis (a build-up of bile in the liver) over 12 months, and whether it is safe to take.

Eligible Conditions
  • Primary Biliary Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Composite endpoint of ALP and total bilirubin
Secondary outcome measures
Change in baseline numerical rating scale (NRS)
Normalization of ALP

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Seladelpar 5 mgExperimental Treatment1 Intervention
Group II: Seladelpar 10 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seladelpar 5 mg
2021
Completed Phase 3
~200
Seladelpar 10 mg
2021
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
3,063 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers looking for more participants in this trial at the moment?

"According to the latest information on clinicaltrials.gov, this trial is not currently looking for new patients. The study was originally posted on 4/21/2021 but has not been updated since 11/7/2022. However, there are 53 other trials that are still recruiting participants."

Answered by AI

What is the research history of Seladelpar 5 mg?

"Seladelpar 5 mg was first trialled in 2017 at Soon Chun Hyang University Hospital Bucheon. Since then, there have been a total of 18293 completed trials. Currently, 3 more trials are underway with recruitment happening primarily in Jackson, Mississippi."

Answered by AI

In how many distinct sites is this trial active?

"There are 62 clinical trial sites for this medication, for example Southern Therapy and Advanced Research, LLC (STAR) in Jackson, Atlantic Medical Group - Kinston - CAR in Kinston. In total, there are active locations."

Answered by AI

To whom does this particular research project extend eligibility?

"This clinical trial is testing a new treatment for primary biliary cholangitis. To join the study, patients must be aged between 18 and 75. There are 193 spots available in total."

Answered by AI

Could you please expand on Seladelpar's contraindications?

"Seladelpar 5 mg is considered safe by our team at Power. This assessment comes from the fact that Seladelpar is currently in Phase 3 trials, which means that there is both efficacy and safety data supporting its use."

Answered by AI

Have similar trials been conducted in the past?

"There are currently 3 ongoing clinical trials Seladelpar 5 mg in 98 locations and 26 countries. The first study was completed in 2017 by CymaBay Therapeutics, Inc. This Phase 3 drug approval process included 500 participants. A total of 18293 have been completed since then."

Answered by AI

How many people are being given the chance to participate in this research?

"This clinical trial is no longer seeking participants. The first posting was on April 21st, 2021 and the last update was on November 7th, 2022. However, there are 50 other trials actively recruiting patients with primary biliary cholangitis and 3 studies for Seladelpar 5 mg that still need participants."

Answered by AI

For this particular experiment, are researchers only working with test subjects that are middle-aged or older?

"This study is open to patients who are above 18 years old and below 75 years old."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
2021. "RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04620733.
~48 spots leftby May 2025
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