Last updated 6 days ago

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

180 patients around the world
Available in Argentina
Mirum Pharmaceuticals, Inc.
6Research sites
180Patients around the world

This study is for people with

Cholangitis
Primary biliary cholangitis

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study.
Male or female, age ≥18 years at the screening visit.
Confirmed diagnosis of PBC in line with the AASLD guidelines.
UDCA and anti-pruritic medication use will be allowed if meeting additional criteria.
Qualified pruritus associated with PBC as assessed by Adult ItchRO.
Pruritus associated with an etiology other than PBC.
Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events.
Current symptomatic cholelithiasis or inflammatory gallbladder disease.
History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded.
History of Liver transplantation.

Sites

Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Urquiza 3101, Rosario, Santa Fe
Hospital El Cruce - Nestor Kirchner
Recruiting
Av. Calchaquí 5401, Florencio Varela, Provincia de Buenos Aires
Centro Médico Saavedra
Centro Médico Saavedra
Recruiting
Av. Ruiz Huidobro 4693, C1430 Cdad. Autónoma de Buenos Aires, Argentina
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
Recruiting
R. Borges Lagoa, 960, Vila Clementino, São Paulo, SP/BR, 04038-002
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Rua 235 QD. 68 Lote Área, Nº 285, s/nº - Setor Leste Universitário, Goiânia - GO, 74605-050
Hospital de Clínicas de Porto Alegre
Recruiting
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
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