Dupuytren's Contracture Clinical Trial
Official title:
A Phase 3b Open-label, Historically-controlled Study to Assess the Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures With Palpable Cords
The primary objective of this study is to assess the safety of two concurrent injections of
AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable
cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of
occurrence of targeted serious adverse events (tendon rupture/ligament injury and
anaphylaxis) to historical rates of the same in clinical studies and post-marketing
commercial use.
The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.
Methodology/Study Design: After all pre-injection procedures are completed on Day 1, eligible
men and women will receive two concurrent injections AA4500 (AA4500/AA4500) into cord(s)
affecting MP and/or PIP joints on the same or different fingers in the selected hand. A
finger extension procedure to facilitate cord disruption will be performed (after
administration of local anesthesia, if needed) 24 to 72 hours after injection in those
subjects who do not have spontaneous disruption of their cord(s).
Follow up visits for the evaluation of safety and efficacy will be required for all subjects
24 to 72 hours after injection, and on Days 15, 31, and 61.
Upon completion of the day 61 follow-up visit (end of study visit), subjects who require
additional treatment in the treated hand may receive up to three additional injections of
AA4500 according to the XIAFLEX package insert. Subjects may receive up to a total of five
injections and individual cords may receive up to a total of three injections. Subjects who
require additional treatment will be followed for safety.
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