Phase 3
Completed N=6
Collagenase Option for Reduction of Dupuytren's Contracture in Japan
Dupuytren's Contracture
Source: ClinicalTrials.gov NCT01588353 ↗
Enrolled (actual)
6
Serious AEs
13.7%
Results posted
Feb 2017
Primary outcomePrimary: The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less" — 86 % Participants
◆ Published Evidence
Emerging
16citations · ~2 / year
Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population.
Summary
To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.
To determine plasma concentration after the first injection of AK160 in patients with Dupuytren's Contracture.
Linked Publications
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Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less" |
86 | — |
| SECONDARY Clinical Improvement After the Last Injection |
100; 90.0; 96.1 | — |
| SECONDARY Percent Reduction From Baseline Contracture After the Last Injection |
97.08; 82.48; 91.39 | — |
| SECONDARY Change From Baseline Range of Motion After the Last Injection |
41.6; 33.3; 38.4 | — |
| SECONDARY Time to First Achieve and Maintain Clinical Success After the Last Injection |
1.0; 7.0; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- At least 20 years old when written informed consent is obtained.
- Having a diagnosis of Dupuytren's contracture and flexion contracture due to palpable cord in at least 1 non-thumb finger (20° to 100° in MP joint and 20° to 80° in PIP joint).
- Positive tabletop test result (i.e., cannot simultaneously place affected finger and palm on a table).
- Voluntary written informed consent is obtained.
Exclusion Criteria
Patients meeting any of the following criteria will be excluded:
- Is pregnant, may be pregnant, wishes to become or could become pregnant during the study (i.e., unless acceptable contraception is used, the patient has been sterilized, or the patient is postmenopausal [no menstrual period for at least 12 months without any other medical cause]), or is breastfeeding.
- Has a coexisting chronic disease of the hand that could impact assessment (muscular disease, neurological disease, neuromuscular disease).
- Has received another investigational product 30 or fewer days before first injection of the investigational product.
- Has undergone aponeurectomy, aponeurotomy, needle aponeurotomy/fasciotomy, verapamil/interferon injection, or another Dupuytren's Contracture treatment of the primary joint 90 or fewer days before first injection of the investigational product.
- Is allergic to collagenase or any of the excipients of AK160.
- Has taken tetracycline derivative such as minocycline and doxycycline 14 or fewer days before first injection of the investigational product.
- Has received a collagenase product 30 or fewer days before first injection of the investigational product.
- Is currently taking or has taken, 7 or fewer days before first injection of the investigational product, an anticoagulant or antiplatelet drug (other than ≤150 mg/day of aspirin).
- Has suffered a recent stroke, hemorrhage, or other disease affecting the hands.
- Has a serious disease unsuited for the study.
- Receiving treatment for a malignancy.
- History of drug or alcohol addiction within the past 5 years or history of drug or alcohol abuse within the past year.
- Has received previously the investigational product (AK160, AA4500, XIAFLEX®, or XIAPEX®).
- Otherwise found ineligible as a subject by the investigator.
Data sourced from ClinicalTrials.gov (NCT01588353) and the linked publication. 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. Informational only — not medical advice.