Status:
COMPLETED
Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis
Lead Sponsor:
George Brewer
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- Generally medically healthy
- Age 18 and older
- Documented primary biliary cirrhosis
- Alkaline phosphatase \> 137
Exclusion
- Severe liver decompensation
- Requirement for renal dialysis
- Pregnancy or nursing
- Meld score \> 15 (13-15 will require a physician's clinical judgment)
- Uncontrolled congestive heart failure
- Severe diabetic neuropathy
- Severe pulmonary disease
- Advanced cancer
- Requirement for steroid therapy
- Uncontrolled ascites, variceal hemorrhage or spontaneous bacterial peritonitis
- Pregnant or nursing
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00805805
Start Date
April 1 2006
End Date
December 1 2008
Last Update
May 23 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109