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Selective PPAR-delta agonist

Seladelpar for Primary Biliary Cholangitis (AFFIRM Trial)

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
Must have a confirmed prior diagnosis of PBC
Evidence of cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

AFFIRM Trial Summary

This trial tests if a new drug can help people with PBC and compensated cirrhosis to improve their symptoms.

Who is the study for?
This trial is for adults aged 18-75 with Primary Biliary Cholangitis (PBC) and compensated cirrhosis. Participants must have a Child-Pugh (CP) Score of A or B, use dual contraception methods, and be able to follow the study's procedures. Exclusions include those with conditions that may interfere with the study, prior liver transplants, decompensated cirrhosis, certain lab values outside set limits, or previous seladelpar exposure.Check my eligibility
What is being tested?
The trial is testing Seladelpar at a dose of 10 mg against a placebo to see its effect on clinical outcomes in patients with PBC and compensated cirrhosis. The goal is to determine if Seladelpar can improve health markers in these patients compared to not receiving the active drug.See study design
What are the potential side effects?
While specific side effects for Seladelpar are not listed here, similar medications often cause gastrointestinal symptoms like nausea or diarrhea, potential liver enzyme elevations, fatigue, itching (pruritus), and possible allergic reactions.

AFFIRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been previously diagnosed with primary biliary cholangitis (PBC).
Select...
I have been diagnosed with cirrhosis.
Select...
I am between 18 and 75 years old.
Select...
I am using two forms of birth control during and 90 days after the study.

AFFIRM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Event Free Survival (EFS)
Secondary outcome measures
Liver transplant-free survival
Overall survival
Time to Event Free Survival (EFS)
+1 more

Side effects data

From 2020 Phase 3 trial • 265 Patients • NCT03602560
9%
Abdominal pain upper
7%
Upper respiratory tract infection
6%
Headache
6%
Dry mouth
6%
Constipation
6%
Nausea
6%
Arthralgia
4%
Diarrhoea
4%
Cough
3%
Nasopharyngitis
3%
Dry eye
3%
Dyspepsia
3%
Pruritus
3%
Pruritus generalised
2%
Fatigue
2%
Sinusitis
2%
Urinary tract infection
2%
Back pain
1%
Gastrooesophageal reflux disease
1%
Adenoid cystic carcinoma
1%
Muscle spasms
1%
Insomnia
1%
Abdominal distension
1%
Cognitive disorder
1%
Leukocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Seladelpar 5/10 mg
Seladelpar 10 mg
Placebo

AFFIRM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Seladelpar 10 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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
3,064 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 geriatric individuals permitted to join this scientific trial?

"This trial has an eligibility range of 18 to 75 years old."

Answered by AI

To what degree is Seladelpar 10 mg securely tolerated by people?

"Seladelpar 10 mg's safety has been substantiated through prior clinical studies, earning it a score of 3."

Answered by AI

What criteria must a patient meet to qualify for this medical experiment?

"To qualify for this research, individuals must have primary biliary cirrhosis and be between 18 to 75 years old. In total, 192 participants are being recruited."

Answered by AI

Are there a plethora of hospitals participating in the Canadian trial?

"Patients can enroll in this study at California Liver Research Center in Pasadena, Florida Research Institute LLC in Lakewood Ranch, and Mercy Medical Centre located in Baltimore as well as 5 other centres."

Answered by AI

Are there vacancies for participants in this research program?

"Affirmative. Clinicaltrials.gov states that this clinical research is actively searching for participants, with the trial first posted on September 7th 2023 and last updated on the 18th of same month. Currently, 192 patients are needed to be recruited from 5 distinct medical sites."

Answered by AI

What is the cap on the number of individuals enrolled in this research trial?

"Affirmative. The information on clinicaltrials.gov conveys that this research is presently inviting participants. It was originally posted on September 7th 2023, and last revised on the 18th of the same month. For a successful completion, it requires 192 individuals to be recruited from 5 separate facilities."

Answered by AI

Who else is applying?

What site did they apply to?
University Hospitals Cleveland Medical Center
California Pacific Medical Center - Sutter Pacific Medical Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have had @ 5 yrs. of rotating antibiotics and almost 20 years of usrodial. when that stops working perhaps yours will work and i'd like to try it.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
2023. "Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06051617.
All > Liver Cirrhosis > Primary Biliary Cirrhosis
~128 spots leftby Jul 2029
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