SCHOOL OF MEDICINE

Department of Medicine

IU Liver Research

Primary Biliary Cholangitis

 

Raj Vuppalanchi, MD
Dr. Craig Lammert, 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
Enrolling: Yes
Principal Investigator: Dr. Raj Vuppalanchi
Duration: 6 - 8 years
Patient Population: PBC with total bili>ULN and ≤3x ULN or ALP >5x ULN
Drug(s): Obeticholic acid tablet, or placebo

Contact:
Holly King
(317) 278-6200
hrking1@iu.edu

Cara PBC
Enrolling: Yes
Principle Investigator: Dr. Raj Vuppalanchi
Duration: 21 weejs
Patient Population: Patients with moderate to severe itching.
Drug: Oral CR845

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

Zydus PBC
Enrolling: Yes
Principle Investigator: Dr. Raj Vuppalanchi
Duration: 26 weeks
Patient Population: Non-cirrhotic.
Drug: Oral Saroglitazar

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

PBC Itch
Enrolling: Yes
Principle Investigator: Dr. Craig Lammert
Duration: 1 visit
Patient Population: PBC/Pre-transplant and history of no/minimal itch or severe itch

Contact:
Kelsey Green
(317) 278-9292
greenke@iu.edu

Closed Studies:

A Phase 3, Double Blind, Placebo Controlled Trial and LTSE of OCA in Subjects with PBC
Enrolling: No
Duration: LTSE Phase - 5 years
Drug(s): Obeticholic acid, 5 or 10mg

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, 8 and 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 10mg