Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

PHASE3CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Primary Biliary Cirrhosis
Interventions
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

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

FDA Office of Orphan Products Development

FED

lead

George Brewer

OTHER

NCT00805805 - Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis | Biotech Hunter | Biotech Hunter