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Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Michigan
Ann Arbor, Michigan, United States
Start Date
April 1, 2006
Primary Completion Date
December 1, 2008
Completion Date
December 1, 2008
Last Updated
May 23, 2017
29
ACTUAL participants
Tetrathiomolybdate
DRUG
Placebo
OTHER
Lead Sponsor
George Brewer
Collaborators
NCT03301506
NCT02846896
NCT03112681
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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