|Sponsor / Funder||ISIS Pharmaceutical|
|CI||Dr Carol Whelan|
Prof. Mary Reilly
|UK sites||The National Amyloidosis Centre / London Queen Square|
This is a multi-centre, randomised, double-blind, placebo-controlled study.
(ISIS 420915 or placebo) will be given three times on alternate days
during Week 1 (Days 1, 3 and 5), and then once weekly during Weeks 2-65 (for a
total of 67 doses).
Patients will also receive daily supplements of the
recommended dose of vitamin A.
The end of treatment efficacy assessment takes
place at Week 66.
Following completion of this study, eligible patients may
enrol in an open-label extension study.
Otherwise, patients will enter the 6 month post-treatment evaluation part of the study.
Approximately 195 patients in a 2:1 ratio. 130 patients receiving 300 mg ISIS 420915 and 65 patients receiving placebo.