A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia
This is a Phase IV, open label (all people know the identity of the intervention),
multi-center, observational (a scientific study to make a clear and easy understanding of
the cause and effect relationship) study of bendamustine. The study duration is of 24 Weeks
to coincide with the 4 weeks-6 cycles bendamustine treatment. The study will run for three
years, and will enroll 10 percent of patient who would use this product, as a requirement of
the Philippine Food and Drug Administration (FDA). Approximately fifty patients will be
enrolled in this study. Safety evaluations including adverse events, clinical laboratory
tests, electrocardiogram, vital signs, and physical examination will be monitored throughout
the study.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Number of patients with incidence of adverse events
Up to Week 24
Yes
Jannsen Pharmaceutica Clinical trial
Study Director
Jannsen Pharmaceutica
Philippines : Food and Drug Administration
CR100917
NCT01739491
October 2014
November 2016
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