Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

This study has been completed.

Sponsor:

Collaborator:

FDA Office of Orphan Products Development

Information provided by:

University of Michigan

ClinicalTrials.gov Identifier:

NCT00805805

First received: December 8, 2008

Last updated: January 25, 2013

Last verified: December 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	December 8, 2008
Last Updated Date	January 25, 2013
Start Date ^ICMJE	April 2006
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 8, 2008)	Improvement in drug treated group vs placebo group in two liver function tests and one serum cytokine measurement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00805805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 8, 2008)	Improvement in drug treated group vs placebo group in serum CRP or interleukin-1-beta-levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis
Official Title ^ICMJE	Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Primary Biliary Cirrhosis
Intervention ^ICMJE	Drug: Tetrathiomolybdate 120 mg/day, divided as 20 mg three times/day with meals and 60 mg away from food at bedtime, for one week to test gastric tolerance. Increased to 180 mg/day, divided as 40 mg three times/day with meals and 60 mg away from food at bedtime. Serum ceruloplasmin levels measured weekly will be used as a surrogate measure of copper status, with a target of 10-15 mg/dl (normal 20-40). When target Cp levels are reached, usually in 4-8 weeks, a maintenance dose of usually 40-80 mg of TM/day, divided half with a major meal, and half away from food at bedtime will be established (vary from 10 mg to 120 mg/day). Other: Placebo Arm 2 will basically mirror Arm 1 with the patients receiving 120 mg/day, divided as 20 mg three times/day with meals and 60 mg away from food at bedtime the first week. Increased to 180 mg/day, divided as 40 mg three times/day with meals and 60 mg away from food at bedtime. With the dosage being reduced at about the same frequency as the patients receiving TM
Study Arm (s)	Experimental: 1 Tetrathiomolybdate with ursodiol Intervention: Drug: Tetrathiomolybdate Placebo Comparator: 2 Placebo with ursodiol Intervention: Other: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	29
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00805805
Other Study ID Numbers ^ICMJE	PBC
Has Data Monitoring Committee	Yes
Responsible Party	Fred Askari MD, PhD, Principal investigator, Univeristy of Michigan
Study Sponsor ^ICMJE	University of Michigan
Collaborators ^ICMJE	FDA Office of Orphan Products Development
Investigators ^ICMJE	Not Provided
Information Provided By	University of Michigan
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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