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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Biliary Cirrhosis | Drug: Tetrathiomolybdate Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Tetrathiomolybdate with ursodiol
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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). |
Placebo Comparator: 2
Placebo with ursodiol
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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 |
- Improvement in drug treated group vs placebo group in two liver function tests and one serum cytokine measurement [ Time Frame: 2 years ]
- Improvement in drug treated group vs placebo group in serum CRP or interleukin-1-beta-levels [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805805
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Responsible Party: | George Brewer, Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT00805805 |
Other Study ID Numbers: |
PBC |
First Posted: | December 10, 2008 Key Record Dates |
Last Update Posted: | May 23, 2017 |
Last Verified: | May 2017 |
Copper ceruloplasmin tetrathiomolybdate |
Liver Cirrhosis Liver Cirrhosis, Biliary Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Tetrathiomolybdate |
Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |