Blood sample collection from PBC patients at Indiana University

C
Craig Lammert, MD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
3 Locations

Brief description of study

Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease characterized by destruction of the interlobular bile ducts, which, if untreated, leads to fibrosis, biliary cirrhosis, and liver failure. Because liver transplantation remains the only curative option for PBC, the goals of treatment are to slow the rate of progression, to alleviate related symptoms, and to prevent complications. Ursodeoxycholic acid is the only US Food and Drug Administration-approved medical treatment of PBC.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients will be identified and recruited via IU Hepatology Clinic, IU Liver Transplant Clinic, and invitation letters to outside Gastroenterologist for referral of PBC patients.

Detailed description of study

We would like to collect approximately 12 ml of blood from 200 subjects diagnosed with PBC. The blood will be separated into plasma and serum and then placed in aliquots and frozen. Samples will be used to develop biorepository for future research on PBC at IU School of Medicine. These samples may be used for collaborative research with both on-and off-site investigators.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Primary biliary cirrhosis, PBC
  • Age: 18 years or above
  • Gender: All

Inclusion criteria:


o    Male and Female adults ages ≥18 years old

o    PBC defined as present when two of the three following criteria have been met:

1.    Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.

2.    Positive anti-mitochondrial antibodies (AMA) in serum.

3.    Liver biopsy compatible with the diagnosis of PBC.

Updated on 16 Dec 2025. Study ID: GI-IIR-LAMMERT-PBCBANK, 1309342717
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only