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FXR Agonist

Seladelpar for Primary Biliary Cholangitis

Phase 3
Recruiting
Research Sponsored by Gilead Sciences
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
Must not have
Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
For females, pregnancy or breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver disease is advanced, with low albumin and high bilirubin levels.
Select...
I am not pregnant or breastfeeding.
Select...
My kidney function is reduced, with an eGFR of 45 or less.
Select...
I haven't taken colchicine, methotrexate, azathioprine, or long-term steroids in the last 2 months.
Select...
I have autoimmune hepatitis.
Select...
I have a known history of alpha-1-antitrypsin deficiency.
Select...
I have been diagnosed with primary sclerosing cholangitis.
Select...
I stopped taking seladelpar for PBC due to side effects.
Select...
I am not currently on any immunosuppressant therapies.
Select...
I have a history of chronic viral hepatitis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Ascites
Change in MELD
Death
+13 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

Gilead SciencesLead Sponsor
1,130 Previous Clinical Trials
866,627 Total Patients Enrolled
CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
2,756 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
358 Previous Clinical Trials
191,616 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
~181 spots leftby Nov 2028
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