Dupuytren's Contracture Clinical Trial
Official title:
An Open-label Study to Assess the Safety and Efficacy of Concurrent Administration of Two Injections of AA4500 0.58 mg Into the Same Hand of Subjects With Multiple Dupuytren's Contractures
The objectives of this study are to assess the safety and efficacy of concurrent administration of two injections of AA4500 into the same hand of subjects with multiple Dupuytren's contractures caused by palpable cords.
Methodology/Study Design:
This is an open-label, study in men and women with multiple Dupuytren's contractures.
Approximately 60 subjects who have at least two Dupuytren's contractures caused by palpable
cords in the same hand will be enrolled.
After all pre-injection procedures are completed on Day 1, eligible men and women will
receive two concurrent injections of AA4500 0.58 mg into the same hand. On Day 2, a finger
extension procedure to facilitate cord disruption will be performed 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 on Day 8, Day 30, and Day 60.
Upon completion of the Day 60 follow-up visit, subjects who require further treatment will
have the option to receive three additional open-label treatments according to the XIAFLEX
package insert (Appendix C). Subjects may receive up to a total of five injections and
individual cords may receive up to a total of three injections.
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