Clinical Trials List
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
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/11
Investigators and Locations
Co-Principal Investigator
- 洪俊銘 無
- Jia-Horng Kao 無
- Chun-Jen Liu 無
- PEI-JER CHEN 無
- 曾岱宗 無
- 楊宏志 無
- Shih-Jer Hsu 無
- 鄭永銘 無
- Chen-Hua Liu 無
- 吳志宏 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 王志文 無
- Chia-Yen Dai 無
- 梁博程 無
- Chung-Feng Huang 無
- 魏鈺儒 無
- Jee-Fu Huang 無
- Ming-Lun Yeh 無
- Wan-Long Chuang 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
a.因任何原因死亡
b.肝臟移植
c.MELD 評分 ≥ 15
d.需要治療的腹水
e.因發生以下任何符合條件的事件而住院：
i.食道或胃靜脈曲張出血
ii.肝性腦病變（定義為 West Haven 評分 ≥ 2）
iii.透過診斷性腹腔穿刺術，依據 WBC 計數、分類、和/或嗜氧和/或厭氧血液培養瓶生長呈陽性，確認為自發性細菌性腹膜炎
有關評估需要裁定之臨床事件的更多詳細資訊。
2.評估治療引發不良事件 (TEAE)；生物化學和血液學實驗室評估
Inclution Criteria
Individuals must meet the following criteria to be eligible for study participation:
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) ≤ 0.6 × ULN or ≥ 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
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Taiwan
42 participants
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Global
318 participants
