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

Biliary Tract Disorders

Primary Biliary Cholangitis

1. GFT505B-216: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80mg and 120mg After 12 Weeks of treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid.

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

2. 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

3. CymaBay: An 8-week, dose ranging, open label, randomized, Phase 2 study with an 18-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Diane Sabogal
  • Contact: (305) 243-1501 / d.sabogal@med.miami.edu

4. Novartis: double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of LJN452 in patients with Primary Biliary Cholangitis

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Diane Sabogal
  • Contact: (305) 243-1501 / d.sabogal@med.miami.edu

5. Intercept 747-302 – A Phase 3b, Placebo-Controlled, Multicenter Study, Evaluate Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis

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

6. Gilead GS-4024: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Biliary Cholangitis without Cirrhosis

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Claudia Cottone
  • Contact: (305) 243-1104 / cxc1335@med.miami.edu

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

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Claudia Cottone
  • Contact: (305) 243-1104 / cxc1335@med.miami.edu

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

Primary Sclerosing Cholangitis

1. Tobira: A Phase 2 Proof of Concept Study Investigating the Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects with Primary Sclerosing Cholangitis (PSC)

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Diane Sabogal
  • Contact: (305) 243-1501 / d.sabogal@med.miami.edu

2. Gilead GS-4025: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Claudia Cottone
  • (305) 243-1104 / cxc1335@med.miami.edu