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Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

Primary Purpose

Primary Biliary Cirrhosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tetrathiomolybdate
Placebo
Sponsored by
George Brewer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring Copper, ceruloplasmin, tetrathiomolybdate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Tetrathiomolybdate with ursodiol

Placebo with ursodiol

Outcomes

Primary Outcome Measures

Improvement in drug treated group vs placebo group in two liver function tests and one serum cytokine measurement

Secondary Outcome Measures

Improvement in drug treated group vs placebo group in serum CRP or interleukin-1-beta-levels

Full Information

First Posted
December 8, 2008
Last Updated
May 19, 2017
Sponsor
George Brewer
Collaborators
FDA Office of Orphan Products Development
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1. Study Identification

Unique Protocol Identification Number
NCT00805805
Brief Title
Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis
Official Title
Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
George Brewer
Collaborators
FDA Office of Orphan Products Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
Copper, ceruloplasmin, tetrathiomolybdate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tetrathiomolybdate with ursodiol
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo with ursodiol
Intervention Type
Drug
Intervention Name(s)
Tetrathiomolybdate
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in drug treated group vs placebo group in two liver function tests and one serum cytokine measurement
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Improvement in drug treated group vs placebo group in serum CRP or interleukin-1-beta-levels
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

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