AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Public ClinicalTrials.gov record NCT00528424. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00528424
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 286 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2007
- Primary completion
- Oct 31, 2008
- Completion
- Oct 31, 2008
- Last update posted
- Dec 1, 2017
2007 – 2008
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 100 UCLA Medical Plaza, Suite 305 | Los Angeles | California | 90095 | — |
| Hand Surgery Clinic | Palo Alto | California | 94304 | — |
| Hand Surgery Associates, PC | Denver | Colorado | 80210 | — |
| The Hand and Upper Extremity Center of Georgia, P.C. | Atlanta | Georgia | 30342 | — |
| Rockford Orthopedic Associates, Ltd. | Rockford | Illinois | 61107 | — |
| The Indiana Hand Center | Indianapolis | Indiana | 46260 | — |
| Brigham and Women's Hospital, Department of Orthopedic Surgery | Boston | Massachusetts | 02115 | — |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | — |
| TRIA Orthopaedic Center | Minneapolis | Minnesota | 55431 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| SUNY Stony Brook - Department of Orthopedics | Stony Brook | New York | 11794 | — |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | — |
| Hand Microsurgery & Reconstructive Orthopaedics | Erie | Pennsylvania | 16550 | — |
| University Orthopedics Center | State College | Pennsylvania | 16801 | — |
| Department of Orthopaedics, Brown University, Rhode Island Hospital | Providence | Rhode Island | 02905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00528424, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00528424 live on ClinicalTrials.gov.