Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
The University of Michigan is conducting a study investigating a 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 the study for each patient is 24 months of drug therapy. Lab
draws will be necessary weekly for the first 6 weeks of the study, followed by every other
week for 3 weeks, and then monthly for the remainder of the 2 year period. In addition,
intermittent history and physicals 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