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

Biliary Tract Disorders

Primary Biliary Cholangitis

1. Glaxo Smith Kline: A randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of several repeat dose levels of GSK2330672 administration in patients with Primary Biliary Cholangitis (PBC) Pruritus

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Odalys Rodriguez
  • Contact: (305) 243-4648 / obravo@med.miami.edu

2. Target: A 5-year longitudinal, observational study of patients with primary biliary cholangitis

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Tiffannia Grant
  • Contact: (305) 243-4649 / t.grant11@med.miami.edu

3.GSN000300: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Maria Lourdes Onate
  • Contact: (305) 243-6939 / malourdeso@med.miami.edu

4. EDP305-201: A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC)with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Tiffannia Grant
  • Contact: (305) 243-4649 / t.grant11@med.miami.edu

5. Intercept 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

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu

Lilly 14V-MC-JAIV: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA

  • Status: Future Trial
  • PI: Dr. Cynthia Levy
  • Coordinator: Katheryn Dae
  • Contact: (305) 243-1104 / kqd1@med.miami.edu

CB8025-31735: A 52-week, Placebo-Controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

  • Status: Future Trial
  • PI: Dr. Cynthia Levy
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu

Primary Sclerosing Cholangitis

1. Hightide: A proof-of-concept and dose-ranging study investigating the efficacy and safety of HTD1801 in adult subjects with Primary Sclerosing Cholangitis (PSC)

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Tiffannia Grant
  • (305) 243-4649 / t.grant11@med.miami.edu

2. Durect: A randomized, open-label, Phase 2 study to evaluate safety and efficacy of DUR-928 in subjects with Primary Sclerosing Cholangitis (PSC)

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Tiffannia Grant
  • Contact: (305) 243-4649 / t.grant11@med.miami.edu

3. BWH: A Randomized, Placebo-Controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis

  • Status: Future Trial
  • PI: Dr. Cynthia Levy
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu