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| Sponsor / Funder | ISIS Pharmaceutical |
| CI | Dr Carol Whelan |
|
PI |
Prof. Mary Reilly听 |
| UK sites | The National Amyloidosis Centre / London Queen Square |
| 听 |
Trial information
This is a multi-centre, randomised, double-blind, placebo-controlled study.
Study drug
(ISIS听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听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听month post-treatment evaluation part of the study.
Recruitment
Approximately 195 patients in a 2:1 ratio. 130 patients receiving 300 mg ISIS听420915 and 65 patients receiving placebo.