Dear PBCers,

We have initiated a pilot research study that will investigate a novel therapy for the treatment of PBC.

The drug acts by inhibiting the immune response and we hope will prove to be beneficial for PBC patients who do not respond to Urso. To be eligible, participants must be

• Female between the ages of 18 and 65 years
• Positive serum AMA at titer >1:40
• A liver biopsy consistent with PBC and stage 1, 2 or 3
• Alkaline phosphatase more than 2 times the normal value for more than 6 months while on Urso
• Negative pregnancy test in female patients of fertile age
• Normal kidney function

The study will take place at the UC Davis Medical Center in Sacramento, CA.

After an initial evaluation, eligible participants will receive 2 infusions of the medications separated by 2 weeks. Clinic visits and laboratory testing will be required 4, 8, 16, 24, 36 and 52 weeks after starting the treatment. All study medications, clinic visits and testing will be covered by the study. Travel, meals and accommodations during the study will be the responsibility of the participants.

If you are interested in learning more about this study and if you qualify, please contact me by email at megershwin@ucdavis.edu.

Sincerely,

M.Eric Gershwin M.D.

Distinguished Professor of Medicine

The Jack and Donald Chia Professor of Medicine

Chief, Division of Rheumatology, Allergy and Clinical Immunology

Genome and Biomedical Sciences Facility

University of California at Davis

451 E. Health Sciences Drive, Suite 6510

Davis, CA 95616

Phone 530 752 2884

Fax 530 752 4669

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