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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

ConditionPrimary Biliary Cholangitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences

About this trial

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be at least 18 years old.

Must have a confirmed prior diagnosis of PBC

Evidence of cirrhosis

CP Score A or B

Disqualifiers

Prior exposure to seladelpar

A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study

History of liver transplantation or actively listed for cadaveric or planned living donor transplant.

Decompensated cirrhosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Seladelpar

    Drug

    * Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or * Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis.

  • Placebo

    Drug

    One capsule daily for up to 36 months.

Treatment groups

318 Participants
are divided into 2 treatment groups
Group A: SeladelparExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Event Free Survival (EFS)

EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events: 1. Death by any cause; 2. Liver transplantation; 3. MELD score ≥15; 4. Ascites requiring treatment; 5. Hospitalization for any of the following: 1. Esophageal or gastric variceal bleeding 2. Hepatic encephalopathy 3. Spontaneous bacterial peritonitis

Time frame
36 months

Secondary outcomes

1

Overall survival

Time from start of treatment to death from any cause.

Time frame
36 months
2

Liver transplant-free survival

Time from start of treatment to the first occurrence of liver-related death or liver transplantation.

Time frame
36 months
3

Time to hospitalization

Time from start of treatment to the first occurrence of hospitalization for qualifying PBC clinical events

Time frame
36 months
4

Time to Event Free Survival (EFS)

1. MELD score ≥15 2. Ascites requiring treatment

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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