SCHOOL OF MEDICINE

Department of Medicine

IU Liver Research

Primary Biliary Cholangitis

 

Raj Vuppalanchi, MD
Relevent Investigator(s)
 


 

Primary Biliary Cholangitis is a condition in which the liver slowly deteriorates and is unable to function normally due to chronic, or long lasting, injury. Scar tissue replaces healthy liver tissue and partially blocks the flow of blood through the liver.


Current studies:

Intercept 302 PBC Study
Enrolling: Yes
Duration: 6-8 years
Primary Outcomes measured: Composite Endpoint of  six events listed below:

  • Death
  • Liver transplant
  • MELD score >=15
  • Uncontrolled ascites
  • Hepatocellular carcinoma
  • Hospitalization for new onset or recurrence of any of the following:
    • Variceal bleed
    • Encephalopathy
    • Spontaneous bacterial peritonitis

Drug(s): obeticholic acid and placebo

Contact information:
Rachel Lee
317-278-6266
Lee352@iu.edu


A Phase 3, Double Blind, Placebo Controlled Trial and LTSE of OCA in Subjects with PBC
Enrolling: No
Duration: LTSE Phase is 5 years

Drug(s): obeticholic acid, 5 or 10 mg

Contact information:
Linda Ragozzino
317-274-3514
lragozzi@iu.edu


A Phase 2 Clinical Trial Investigating the Effects of OCA on Liproprotein Metabolism in Subjects with PBC
Enrolling: No
Duration: 2 years
Primary Outcomes measured: Change from baseline in High-density lipoprotein (HDL) Metabolism [ Time Frame: Week 4, Week 8 and Week 12 ] [ Designated as safety issue: No ]

HDL metabolism will be assessed by measuring HDL cholesterol concentration, HDL particle size and number.

Drug(s): obeticholic acid, 5 or 10 mg

Contact information:
Linda Ragozzino
317-274-3514
lragozzi@iu.edu


PBC Database
Enrolling
: Yes
Duration: 1 visit

Contact information:
Megan Comerford
317-278-9226
mcomerfo@iu.edu


PBC Itch Study
Enrolling
: Yes
Duration: 1 visit

Contact information:
Mandy Cruz
317-278-6215
mandcruz@iu.edu