Clinical trial · Interventional
Collagenase Option for Reduction of Dupuytren's Contracture in Japan
Phase III Study of AK160 in Patients With Dupuytren's Contracture
NCT01588353CI-TRIAL-00026537CORD-JcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dupuytren's Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collagenase Clostridium Histolyticum | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK160 0.58 mg
- interventionNames
- Drug: Collagenase Clostridium Histolyticum
Primary outcomes (1)
- measure
- The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
- timeFrame
- 30 days after the last injection
- description
- The Primary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were successfully treated where "successfully treated" was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times.
Secondary outcomes (4)
- measure
- Clinical Improvement After the Last Injection
- timeFrame
- 30 days after the last injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTHirata H, Tanaka K, Sakai A, Kakinoki R, Ikegami H, Tateishi N. 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. J Hand Surg Eur Vol. 2017 Jan;42(1):30-38. doi: 10.1177/1753193416653249. Epub 2016 Sep 28. PMID 27313184