Clinical trial · Interventional
Retreatment of Recurrent Dupuytren's Contractures
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
NCT01498640CI-TRIAL-00029785completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dupuytren's Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collagenase clostridium histolyticum | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- XIAFLEX/XIAPEX MP Joint
- description
- Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
- interventionNames
- Biological: Collagenase clostridium histolyticum
- type
- EXPERIMENTAL
- label
- XIAFLEX/XIAPEX PIP Joint
- description
- Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
- interventionNames
- Biological: Collagenase clostridium histolyticum
Primary outcomes (3)
- measure
- Clinical Success
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provide written informed consent 2. Be currently participating in the AUX-CC-860 follow-up study 3. Have at least one joint with all of the following: * The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study * The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study * A palpable cord is present in the joint to be treated 4. Be able to comply with the study visit schedule as specified in the protocol Exclusion Criteria: 1. Is a pregnant or lactating female or female intending to become pregnant during the study 2. Has hypersensitivity to AA4500 or any of the AA4500 excipients 3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs \[NSAIDs\]) within 7 days before injection of AA4500
References
Publications (0)
Data not yet available
No reference posted for this study.