Phase 1
N=16
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
Dupuytren's Contracture
Bottom Line
View on ClinicalTrials.gov: NCT00528931 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Aug 2012
Primary outcome: Primary: Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500 — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- collagenase clostridium histolyticum (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500 |
— | — |
| SECONDARY Clinical Success |
75.0 | — |
| SECONDARY Clinical Improvement |
100.0 | — |
| SECONDARY Percent Change From Baseline Contracture |
91.6 | — |
| SECONDARY Change From Baseline Range of Motion |
39.1 | — |
Summary
A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection.
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.
Eligibility Criteria
Inclusion Criteria
- Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
- Had a positive "table top test, " defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- Were naive to AA4500 treatment.
- Were judged to be in good health.
Exclusion Criteria
- Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- Had received treatment for Dupuytren's contracture within 90 days of the AA4500 injection to the MP or PIP selected, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
- Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
Data sourced from ClinicalTrials.gov (NCT00528931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.