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Clinical Trials List

Protocol NumberCB8025-41837

NCT Number(ClinicalTrials.gov Identfier)NCT06051617

Not yet recruiting

2025-12-01 - 2032-08-02

Others

Not yet recruiting7

ICD-10K83.0

Cholangitis

ICD-9576.1

Cholangitis

AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Trial Applicant

GILEAD SCIENCES HONG KONG LIMITED
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 蘇東弘無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ming-Lung Yu 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 胡琮輝無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳啟益無

Chia-Yi Christian Hosptal

Co-Principal Investigator

許銘澤無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Wei Su 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Pin-Nan Cheng

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Rong-Nan Chien 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Primary Biliary Cholangitis

Objectives

Primary Objective Efficacy: To evaluate the effect of seladelpar compared to placebo on event-free survival (EFS). EFS is defined as the time elapsed from the start of treatment to the first occurrence of any of the following adjudicated events at week 156: • Death from any cause • Liver transplantation • Model for End-Stage Liver Disease (MELD) score ≥15 • Ascites requiring treatment • Hospitalization due to any of the following qualifying events: o Esophageal or gastric variceal bleeding o Hepatic encephalopathy (defined as West Haven score ≥2) o Spontaneous bacterial peritonitis confirmed by diagnostic paracentesis based on white blood cell (WBC) count, differential, and/or positive growth in aerobic and/or anaerobic blood cultures Safety: To evaluate the safety of seladelpar compared to placebo during the 156-week treatment period Secondary Objective: To evaluate the effect of seladelpar on the following: • Overall survival • Liver transplant-free survival (LTFS) is defined as the time elapsed from the start of treatment to the first occurrence of liver-related death or liver transplantation. • Time elapsed before hospitalization due to any of the following qualifying events: o Esophageal or gastric variceal bleeding o Hepatic encephalopathy or o Spontaneous bacterial peritonitis • Time elapsed before any other qualifying PBC clinical event (MELD score ≥ 15 and ascites requiring treatment) Exploratory Goals: To assess the impact of disease and seladelpar on individual qualifying PBC clinical events, liver biochemical markers of disease and liver injury, liver histology, liver stiffness, disease and/or worsening biomarkers, pharmacokinetics (PK), patient-reported quality of life indicators, PBC prognostic criteria, and pruritus.

Test Drug

Capsules

Active Ingredient

Seladelpar Lysine

Dosage Form

130

Dosage

5 mg or 10 mg

Endpoints

1. Assess EFS by the time elapsed from the start of treatment to the first occurrence of any of the following adjudicated events at week 156:

a. Death from any cause

b. Liver transplantation

c. MELD score ≥ 15

d. Ascites requiring treatment

e. Hospitalization due to any of the following criterion events:

i. Esophageal or gastric variceal bleeding

ii. Hepatic encephalopathy (defined as West Haven score ≥ 2)

iii. Spontaneous bacterial peritonitis confirmed by diagnostic paracentesis based on WBC count, differential, and/or positive growth in aerobic and/or anaerobic blood cultures. More detailed information on clinical events requiring adjudication is available for assessment.

2. Assess treatment-induced adverse events (TEAEs); biochemical and hematological laboratory evaluation.

Inclution Criteria

Must be at least 18 years old.
Must have a confirmed prior diagnosis of PBC
Evidence of cirrhosis
CP Score A or B
Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals 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
Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

Exclusion Criteria

Individuals must not meet any of the following criteria to be eligible for study participation:

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
Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
Hospitalization for liver-related complication within 12 weeks of Screening
Laboratory parameters at Screening:

Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
Total bilirubin (TB) ≥5×ULN
Platelet count ≤50×10^3/µL
Albumin ≤2.8 g/dL
Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2
MELD score >12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
Serum alpha-fetoprotein (AFP) >20 ng/mL
INR >1.7
CP-C cirrhosis
History or presence of other concomitant liver diseases

The Estimated Number of Participants

Taiwan

42 participants
Global

318 participants