Finding studies
Finding studies
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Lead
University of California, San Francisco
This is a phase 1, multi-center, open-label study of the safety, tolerability, pharmacodynamics, and preliminary efficacy of young (\<30 years of age) healthy male donor plasma transfusions in patients with PSP. Up to 10 subjects will receive once monthly 4-unit transfusions of young healthy male donor plasma for 6 months. If ≥3 subjects experience drug limiting toxicity (DLT), as defined in Section 7.19, the study will be terminated. Any subject that experiences a DLT will be discontinued from further treatment with the study drug. An interim futility analysis will be performed after five subjects have completed 6 months of study drug treatment. If the criteria listed in Section 9.3 of this protocol are met, an additional 5 subjects will be enrolled in the trial. If not, the trial will be terminated.
Age
50–85
Sex
ALL
Healthy volunteers
Not accepted
