Collagenase Option for Reduction of Dupuytren's Contracture in Japan

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.