Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

George Brewer

Status and phase: Completed; Phase 3

Conditions: Primary Biliary Cirrhosis

Treatments: Drug: Tetrathiomolybdate; Other: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00805805

PBC

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally medically healthy
• Age 18 and older
• Documented primary biliary cirrhosis
• Alkaline phosphatase > 137

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Tetrathiomolybdate with ursodiol

Treatment:

Drug: Tetrathiomolybdate

2

Placebo Comparator group

Description:

Placebo with ursodiol

Treatment:

Other: Placebo