Clinical Research Trials : Biliary Tract Disorders (PBC and PSC)

Biliary Tract Disorders

CR845-210401-A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL CR845 IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS WITH MODERATE-TO-SEVERE PRURITUS, PAREXEL # 243942
o Classification: PBC/ Pruritis
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Patricia Blenet
o Contact: (305) 243 6968 / pmb45@med.miami.edu

CB8025-31731- An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
o Classification: PBC
o Status: Closed enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Katheryn Dae
o Contact: (305) 243-1104 / kqd1@med.miami.edu

GFT505B-319-1-A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid
o Classification: PBC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Patricia Blenet
o Contact: (305) 243 6968 / pmb45@med.miami.edu

747-401-A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
o Classification: PBC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Diane Sabogal
o Contact: (305) 243-1501 / d.sabogal@med.miami.edu

Intercept 747-302 – A Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis
o Classification: PBC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Lourdes Onate
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

16-005892 -A Resource of Blood and other Biospecimens of Patients with Cholestatic Liver Disease and Unaffected Individuals
o Classification: PSC/PBC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Edgar Medina
o Contact: (305) 243-0236 / ejm202@med.miami.edu

TARGET-PBC-A 5-year longitudinal, observational study of patients with primary biliary cholangitis
o Classification: PBC
o Status: Closed enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Olivia Blust
o Contact: (305) 243-2855 / oib5@med.miami.edu

CB8025-31731-ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
o Classification: PBC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Katheryn Dae
o Contact: (305) 243-1104 / kqd1@med.miami.edu

CB8025-32048-RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
o Classification: PBC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Katheryn Dae
o Contact: (305) 243-1104 / kqd1@med.miami.edu

SARO.20.003 – A Phase 3, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis
o Classification: PBC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Edgar Medina
o Contact: (305) 243-0236 / ejm202@med.miami.edu

GSK-212358- Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis
o Classification: PBC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Luis Cuza
o Contact: lvc36@med.miami.edu / (305) 243-7351

212620: GLISTEN: A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC)
o Classification: PBC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Luis Cuza
o Contact: lvc36@med.miami.edu / (305) 243-7351

HTD1801.PCT013 – A Phase 2 Open-Label Proof-of-Concept Study of HTD1801 (BUDCA) in Adult Subjects with Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy (PRONTO-PBC)
o Classification: PBC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Luis Cuza
o Contact: lvc36@med.miami.edu / (305) 243-7351

BWH – A randomized, placebo-controlled pilot study of sulfasalazine for the treatment of Primary Sclerosing Cholangitis
o Classification: PSC
o Status: Open Enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Patricia Blenet
o Contact: (305) 243 6968 / pmb45@med.miami.edu

GS-US-428-4194-A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis
o Classification: PSC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Lourdes Onate
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

GS-US-428-5443-A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects with Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
o Classification: PSC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Patricia Blenet
o Contact: (305) 243 6968 / pmb45@med.miami.edu

GSK CALID-Investigating the Cholestatic Pruritus of Primary Sclerosing Cholangitis (ItCh-PSC): A study of patients participating in the Consortium for Autoimmune Liver Disease (CALiD)
o Classification: PSC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Edgar Medina
o Contact: (305) 243-0236 / ejm202@med.miami.edu

VLX-301-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 (VISTAS)
o Classification: PSC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Edgar Medina
o Contact: (305) 243-0236 / ejm202@med.miami.edu

Repository prospective study of the prognostic value of transient elastography (Fibroscan) in primary sclerosing cholangitis (PSC) patients
o Classification: PSC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Katheryn Dae
o Contact: (305) 243-1104 / kqd1@med.miami.edu

CALiD North American PSC Patient Registry
o Classification: PSC
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Edgar Medina
o Contact: (305) 243-0236 / ejm202@med.miami.edu

PLN-74809-PSC-203-A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC)
o Classification: PSC
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Edgar Medina
o Contact: (305) 243-0236 / ejm202@med.miami.edu