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Randomized Double Blind Study for
Newly Diagnosed Wilson's Disease Patients Presenting
with Liver Disease Clinical Trial
The University of Michigan, which has been designated a Wilson's Disease Center of Excellence by the Wilson's Disease Association, is conducting a randomized double blind study to compare efficacy and toxicity of three anticopper drugs, penicillamine, trientine, and tetrathiomolybdate, for the initial treatment of Wilson's disease patients presenting with liver disease.
Objectives:
To compare rate and degree of recovery of liver
function, and to compare side effects.
The treatment period is 24 weeks, the first 6 weeks
of which are spent in the General Clinical Research
Center of the University of Michigan Hospital, with
free medical care and hospitalization provided to
the extent required for Wilson's disease. The next
18 weeks involves home treatment, with the appropriate
anticopper medication provided. It will be necessary
to have blood tests every 2 weeks during the 18-week
period at home with the results sent to us. The blood
tests involve blood counts and liver function tests,
readily available anywhere. Patients will be followed
with the referring physician, as desired. Patients
will be responsible for travel costs to Ann Arbor
and for blood tests during the last 18 weeks.
Contact:
Fred Askari, M.D., Ph.D., Associate Professor, Hepatology
Phone: (734) 647-2964, Fax: (734) 763-2535, e-mail:
faskari@med.umich.edu
Randomized, Double Blind Treatment Trial for Newly Diagnosed Wilson's Disease Presenting with Neurologic Symptoms
The University of Michigan is conducting a randomized
double blind trial of two dose regimens of tetrathiomolybdate
for the initial treatment of Wilson's disease patients
presenting with the neurologic symptoms of Wilson's
disease.
The initial treatment period is 16 weeks, the first
6 weeks of which are spent in the General Clinical
Research Center of the University of Michigan Hospital,
with free medical care and hospitalization provided,
to the extent required for Wilson's disease. The next
10 weeks involves home treatment, with the tetrathiomolybdate
medication provided. It will be necessary to have
blood tests every 2 weeks during this 10-week period
with the results sent to us. The blood tests involve
blood counts and liver function tests, readily available
everywhere. We will help arrange subsequent care and
will wish to follow-up and help monitor the patients
on a regular basis over the following 2- to 3-year
period. After initial treatment, patients will be
referred back to the referring physician, if desired.
Contact:
Fred Askari, M.D., Ph.D., Associate Professor, Hepatology
Phone: (734) 647-2964, Fax: (734) 763-2535, e-mail:
faskari@med.umich.edu
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