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

• ClinicalTrials.gov Identifier: NCT01588353
• Recruitment Status: Completed
• First Posted: April 30, 2012
• Results First Posted: February 14, 2017
• Last Update Posted: March 21, 2017
• Sponsor: Asahi Kasei Pharma Corporation
• Information provided by (Responsible Party): Asahi Kasei Pharma Corporation

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Dupuytren's Contracture	Drug: Collagenase Clostridium Histolyticum	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Study of AK160 in Patients With Dupuytren's Contracture
• Study Start Date: May 2012
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: AK160 0.58 mg	Drug: Collagenase Clostridium Histolyticum; AK160 (Collagenase Clostridium Histolyticum) 0.58 mg; Other Names: Xiaflex® (US); Xiapex® (EU)

Outcome Measures

Primary Outcome Measures :

1. The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less" [ Time Frame: 30 days after the last injection ]
   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 Outcome Measures :

1. Clinical Improvement After the Last Injection [ Time Frame: 30 days after the last injection ]
   The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were clinically improved where "clinically improved" was defined as reduction in the contracture of the first treated joint by 50% or more from the baseline. The injection was allowed up to 3 times.
2. Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: 30 days after last treatment ]
   The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the mean percent decrease from baseline degree of contracture in primary joints after the last injection. The injection was allowed up to 3 times.
3. Change From Baseline Range of Motion After the Last Injection [ Time Frame: 30 days after last treatment ]
   The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the change from baseline range of motion in primary joints after the last injection. The injection was allowed up to 3 times.
4. Time to First Achieve and Maintain Clinical Success After the Last Injection [ Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months ]
   The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the time to first achieve and maintain clinical success after the last injection where "clinical success" was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Japan

Aichi, Japan

Aomori, Japan

Chiba, Japan

Fukuoka, Japan

Hiroshima, Japan

Hokkaido, Japan

Ishikawa, Japan

Iwate, Japan

Kanagawa, Japan

Kumamoto, Japan

Kyoto, Japan

Mie, Japan

Nagano, Japan

Nagasaki, Japan

Niigata, Japan

Okayama, Japan

Osaka, Japan

Tokushima, Japan

Tokyo, Japan

Yamaguchi, Japan

Sponsors and Collaborators

Asahi Kasei Pharma Corporation

More Information

Publications of Results:

Hirata 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.

• Responsible Party: Asahi Kasei Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01588353
• Other Study ID Numbers: AK160-III-1
• First Posted: April 30, 2012
• Results First Posted: February 14, 2017
• Last Update Posted: March 21, 2017
• Last Verified: February 2017

Keywords provided by Asahi Kasei Pharma Corporation:

AK160, collagenase clostridium histolyticum

Additional relevant MeSH terms:

Dupuytren Contracture; Contracture; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases