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Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

Primary Biliary Cirrhosis Clinical Trial

Official title:
Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00805805
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase Phase 3
Start date April 2006
Completion date December 2008
View Details
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