At a glance
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A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
In Brief
A Phase 3 clinical trial evaluating collagenase clostridium histolyticum for Advanced Dupuytren's Disease. Completed, enrolled 201 participants across 14 sites.
Detailed Summary
This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for evaluation and injection were enrolled. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
Study Details
Timeline
Interventions
Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.