Collagenase Option for Reduction of Dupuytren's Contracture in Japan

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asahi Kasei Pharma Corporation

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.