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Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

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ClinicalTrials.gov Identifier: NCT00805805
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
George Brewer, University of Michigan

Tracking Information
First Submitted Date  ICMJE December 8, 2008
First Posted Date  ICMJE December 10, 2008
Last Update Posted Date May 23, 2017
Study Start Date  ICMJE April 2006
Actual 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 ]
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: December 8, 2008)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00805805
Other Study ID Numbers  ICMJE PBC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party George Brewer, University of Michigan
Study Sponsor  ICMJE George Brewer
Collaborators  ICMJE FDA Office of Orphan Products Development
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP