Collagenase Option for Reduction of Dupuytren's Contracture in Japan (CORD-J)

Asahi Kasei Medical

Status and phase

Completed

Phase 3

Conditions

Dupuytren's Contracture

Treatments

Drug: Collagenase Clostridium Histolyticum

Study type

Interventional

Funder types

Industry

Identifiers

NCT01588353

AK160-III-1

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.