A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Sclerosing Cholangitis

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT04663308RENIS: IS004666Tipo: INTERVENTIONALInicio: 18 de dic de 2020Fin estimado: 1 de abr de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period.
Subjects aged ≥12 years for eligible regions; otherwise ≥18 years
Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines.
Pruritus associated with PSC as assessed by Adult ItchRO.
Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria.
Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria.

Criterios de exclusión

Pruritus associated with an etiology other than PSC
Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation
Evidence, history, or suspicion of other liver disease; PSC patients with AIH are not excluded.
Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
Exceeding pre-defined biochemical values for alanine aminotransferase/aspartate aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR),serum creatinine (sCr), platelet count, international normalized ratio (INR) and total bilirubin
History of liver transplantation

Intervenciones

drug

Volixibat

Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.

drug

Placebo

Capsules matched to study drug minus active substance

Ubicaciones

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Glenny Corp S.A.

Ciudad Autónoma Buenos Aires, Argentina

Hospital El Cruce

San Juan Bautista, Argentina

Patrocinadores

PrincipalMirum Pharmaceuticals, Inc.

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Randomized Double-Blind Placebo-Controlled Study to Eva... | EligiMed