Collagenase Option for Reduction of Dupuytren's Contracture in Japan
Condition: Dupuytren's Contracture
MeSH terms: Dupuytren Contracture; Contracture
Intervention: Collagenase Clostridium Histolyticum
Intervention description: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: AK160, collagenase clostridium histolyticum

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.
    

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.