At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 52 enrolled
Drug / intervention
Collagenase clostridium histolyticumbiological
Likely dose
Collagenase clostridium histolyticum 0.58 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
In Brief
A Phase 4 clinical trial evaluating Collagenase clostridium histolyticum for Dupuytren's Disease. Completed, enrolled 52 participants across 13 sites in 4 countries.
Detailed Summary
The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDupuytren's Disease
CountriesAustralia, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartMar 2012
Primary CompletionOct 2013
TodayJul 2026
First PostedDec 23, 2011
Enrollment StartMar 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.5 years ago
Interventions
Collagenase clostridium histolyticumbiological
up to three 0.58 mg injections