At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of Dupuytren's contracture with fixed flexion deformity of at least one non-thumb finger.
- ✓Contracture angle between 20° and 100° at MP joints (or ≤80° at PIP joints).
- ✓Deformity caused by palpable cord.
- ✓Positive table-top test (inability to place affected finger(s) and palm flat on table).
- ✕Chronic muscular, neurological, or neuromuscular disorder affecting the hands.
- ✕Any prior Dupuytren's treatment within 90 days, including surgery, needle aponeurotomy, or verapamil/interferon injection.
- ✕Recent history of stroke, bleeding disorder, disease affecting the hands, or other medical condition deemed unsuitable by investigator.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating collagenase clostridium histolyticum for Dupuytren's Contracture. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Single dose of AA4500 0.58 mg into the cord