Advanced Dupuytren's Disease Clinical Trial
Official title:
A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857
(NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study
AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further
treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or
proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less,
the cord affecting that joint received less than three injections of AA4500, or they had
other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option
to receive up to five injections of AA4500 in this extension study. Subjects requiring
further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each
injection, with injections separated by four weeks. Follow-up visits for the determination of
efficacy and safety were conducted on Day 90, Month 6, and Month 9.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00528840 -
Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
|
Phase 3 | |
| Completed |
NCT00533273 -
Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
|
Phase 3 |