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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06051617Tipo: INTERVENTIONALInicio: 7 de sept de 2023Fin estimado: 1 de ago de 2030

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

drug

Seladelpar

* 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.

drug

Placebo

One capsule daily for up to 36 months.

Ubicaciones

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Consultorios Médicos Dr. Doreski - PPDS

Buenos Aires, Argentina

RECRUITING

Buenos Aires Mácula

Buenos Aires, Argentina

RECRUITING

Centro de Investigación y Prevención Cardiovascular

Buenos Aires, Argentina

RECRUITING

AES - AS - Glenny Corp. S.A. Buenos Aires

Buenos Aires, Argentina

RECRUITING

Higea S.A.

Mendoza, Argentina

RECRUITING

DIM Clinica Privada

Ramos Mejía, Argentina

RECRUITING

CINME S.A. - Centro de Investigaciones Metabólicas

Recoleta, Argentina

RECRUITING

Hospital Provincial Del Centenario

Rosario, Argentina

RECRUITING

Patrocinadores

PrincipalGilead Sciences

Contactos

Gilead Clinical Study Information Center

CONTACT

GileadClinicalTrials@gilead.com 1-833-445-3230 (GILEAD-0)

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