Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

Phase 3

Completed

• Conditions: Primary Biliary Cirrhosis
• Interventions: Other: Placebo; Drug: Tetrathiomolybdate

• Registration Number: NCT00805805
• Lead Sponsor: George Brewer

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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-10
• Status Verified: 2017-05
• Disposition First Submitted: 2017-05-19
• Disposition First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Disposition First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo with ursodiol
1	Tetrathiomolybdate	Tetrathiomolybdate with ursodiol

Primary Outcome Measures

Name	Time	Method
Improvement in drug treated group vs placebo group in two liver function tests and one serum cytokine measurement	2 years

Secondary Outcome Measures

Name	Time	Method
Improvement in drug treated group vs placebo group in serum CRP or interleukin-1-beta-levels	2 years

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States