Retreatment of Recurrent Dupuytren's Contractures
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dupuytren's Disease |
Biological: XIAFLEX / XIAPEX |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- The change in degree of flexion from baseline [ Time Frame: 30 days after the last injection of AA4500 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: XIAFLEX / XIAPEX |
Biological: XIAFLEX / XIAPEX
up to three 0.58 mg injections
Other Names:
|
Detailed Description:
Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.
Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provide written informed consent
- Be currently participating in the AUX-CC-860 follow-up study
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
- Be able to comply with the study visit schedule as specified in the protocol
Exclusion Criteria:
- Is a pregnant or lactating female or female intending to become pregnant during the study
- Has hypersensitivity to AA4500 or any of the AA4500 excipients
- 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
Contacts and Locations| United States, Arizona | |
| HOPE Research Institute | |
| Phoenix, Arizona, United States, 85050 | |
| United States, Illinois | |
| Rockford Orthopedic Associates | |
| Rockford, Illinois, United States, 61107 | |
| United States, Indiana | |
| The Indiana Hand to Shoulder Center | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Michigan | |
| Marquette General Health System | |
| Marquette, Michigan, United States, 49855 | |
| United States, New York | |
| East River Professional Building | |
| New York, New York, United States, 10021 | |
| United States, Oklahoma | |
| Health Reserarch Institute | |
| Oklahoma City, Oklahoma, United States, 73109 | |
| United States, Pennsylvania | |
| Hand Microsurgery and Reconstructive Orthopaedics | |
| Erie, Pennsylvania, United States, 16507 | |
| Australia, Queensland | |
| Peninsula Private Hospital | |
| Kippa Ring, Queensland, Australia, 4021 | |
| AusTrials Sherwood | |
| Sherwood, Queensland, Australia, 4075 | |
| Australia, Victoria | |
| Emeritus Research | |
| Malvern East, Victoria, Australia, 3145 | |
| Sweden | |
| Uppsala Akademiska University Hospital | |
| Uppsala, SE, Sweden, SE-751 | |
| United Kingdom | |
| Pulvertaft Hand Center | |
| Derby, GB, United Kingdom, DE22 3NE | |
| Newcastle Upon Tyne Hospitals | |
| Newcastle, GB, United Kingdom, NE1 4LP | |
| Study Director: | Gregory Kaufman, MD | Auxilium Pharmaceuticals, Inc |
More Information
No publications provided
| Responsible Party: | Auxilium Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01498640 History of Changes |
| Other Study ID Numbers: | AUX-CC-862 |
| Study First Received: | December 17, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Therapeutic Goods Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Sweden: Medical Products Agency |
Keywords provided by Auxilium Pharmaceuticals:
|
XIAFLEX XIAPEX Dupuytren's disease contracture |
Additional relevant MeSH terms:
|
Contracture Dupuytren Contracture Joint Diseases |
Musculoskeletal Diseases Muscular Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 22, 2013