We NEED PBCers to participate if possible…………
Ongoing Primary Biliary Cirrhosis Treatment Study
The University of Michigan, Ann Arbor, MI is conducting an ongoing study investigating potential new treatment aimed at slowing/halting progression of primary biliary cirrhosis. This will be a 2 arm double blind study in which half of the patients will be randomly selected to receive a placebo (capsule with no active ingredient) and half will receive the new treatment drug, Tetrathiomolybdate. Neither the patient nor the treating physician will know which arm the patient is in.
The length of this study for each patient is 24 months of drug therapy, plus some time at the beginning involving baseline studies done before starting and possibly 3 months pretreatment with ursodiol. Eligibility criteria include an alkaline phosphatase greater than 1.05 times the upper limit of normal.
At the start of the study, patients will have a history & physical. This is to determine if you are eligible to join the study. If you want to participate in this study, a baseline liver biopsy may be done and blood tests will be done. A minimum of ten (10) visits to University of Michigan will be necessary during the two year period. Patient labs will be arranged to be drawn on a local basis.
If you are eligible, you will be enrolled in a double blind, placebo (no active ingredient) controlled study. Weekly lab draws will be necessary for the first 6 weeks of the study, followed by every other week lab draws for 3 weeks, and then monthly lab draws for the remainder of the 2 year period. In addition, intermittent history and physicals at the University of Michigan Hospital and urine samples will also be necessary.
There is no cost to you for any experimental treatment. All patients in both arms will continue on ursodiol and receive standard of care treatment.
Would you like to hear more details about this exciting new study? Contact Dawna Innis, RN, B.S.N, Clinical Care Coordinator at 734-647-3166 or e-mail dinnis@med.umich.edu
We are hoping a large number of PBCers will be able to participate in this project.
Thanks for your help and consideration.
Linie