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NCT Number: NCT00805805

Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

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

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Key information

Conditions

Primary Biliary Cirrhosis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetrathiomolybdate

Drug

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

Other

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 outcomes

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

George Brewer

Other

Collaborators

  • FDA Office of Orphan Products Development

Registry information

Official study title

Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 10, 2008
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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