IRB Number:

670-02

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to better understand what causes Primary Biliary Cirrhosis (PBC). Current evidence suggests that both genes (the inherited genetic material passed from parents to their children) and environmental factors play a role in the development of PBC. This study will help us better understand the cause(s) of PBC and hopefully find new ways to its prevention, diagnosis and treatment.
Because we are also looking at how PBC may be passed down in families, we are identifying families in which more than one family member has a history of PBC. We are also interested in studying family members of PBC patients who have anti-mitochondrial-antibodies in their blood. These antibodies are present in almost all persons with PBC and are also found in some of their family members who, however, have no evidence of PBC.

Who is Eligible to Participate in the Study?

Men and Women between the ages of 18-90 who have a history of PBC are eligible to participate in this study. PBC patients who have undergone liver transplantation are eligible to participate in this study. Family members of the enrolled PBC patients are also eligible to participate.

1. Men and women between the ages of 18 to 90 who have a history of PBC are eligible to participate in this study. Women of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.


2. The diagnosis of PBC for the patient will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive anti-mitochondrial antibodies (>1:40 titer) and compatible liver biopsies if available.

Minimum Age:

18

Maximum Age:

90

Additional Requirements / Information

As a study participant you will be asked to:

1. Read and sign a written consent form if you wish to participate in this study.


2. Complete a questionnaire about your health status, diet, exercise lifestyle/habits and medical history at the start of the study.


3. Provide information about your family history, contact information for living relatives and your permission to contact other available family members of yours, that are either affected or unaffected by PBC.


4. To provide a sample of your blood (approximately three tablespoons) for genetic testing.

Do I have to visit the Mayo Clinic in order to participate in this study?

No, you do not. If you agree to participate in this study, we will send you a mail-in blood kit and we will ask you to go to your local medical facility to obtain the blood collection. All blood tests and collection of blood specimens will be performed at NO cost to the participants.

Who can I Contact for Additional Information on this Trial?

If you wish to participate in this study or if you have any questions related to this study, please contact Mr. Erik Schlicht at 507-284-4312.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 07/17/2006