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A Study to Evaluate the Safety, Tolerability, and Effectiveness of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis

Overview

Información sobre este estudio

The primary purpose of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: 

  • Diagnosis of large duct PSC.
  • Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0. 
  • F3 fibrosis in the opinion of the central reader. 
  • Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory: 
    • Platelet count ≥ 150,000/mm^3; 
    • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation;
    • ALT ≤ 8 x upper limit of the normal range (ULN);
    • Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia; 
    • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation;
    • Negative anti-mitochondrial antibody.

Exclusion Criteria:

Current or prior history of any of the following:

  • Cirrhosis; 
  • Liver transplantation; 
  • Cholangiocarcinoma or hepatocellular carcinoma (HCC); 
  • Ascending cholangitis within 30 days of screening; 
  • Presence of a percutaneous drain or biliary stent;
  • Other causes of liver disease; 
  • Current or prior history of unstable cardiovascular disease;
  • Current moderate to severely active inflammatory bowel disease (IBD).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

John Eaton, M.D.

Cerrado para la inscripción

More information

Publicaciones

  • Primary sclerosing cholangitis (PSC) is a chronic progressive liver disease leading to biliary fibrosis and cirrhosis. Cilofexor is a nonsteroidal farnesoid X receptor agonist that demonstrated significant improvements in liver biochemistry and markers of cholestasis in patients with PSC in a phase 2 study. We describe here the rationale, design, and implementation of the phase 3 PRIMIS trial, the largest placebo-controlled trial in PSC. Read More on PubMed

Otros temas en investigación

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CLS-20506118

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