A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2017 |
| Start Date: | September 2007 |
| End Date: | March 2008 |
A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of a Single Injection of AA4500 0.58 mg in Subjects With Dupuytren's Contracture
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.
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.
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.
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