Collagenase Option for Reduction of Dupuytren's Contracture in Japan
CORD-J
Phase III Study of AK160 in Patients With Dupuytren's Contracture
1 other identifier
interventional
104
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2012
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
February 14, 2017
CompletedMarch 21, 2017
February 1, 2017
1.7 years
April 27, 2012
July 3, 2016
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
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.
30 days after the last injection
Secondary Outcomes (4)
Clinical Improvement After the Last Injection
30 days after the last injection
Percent Reduction From Baseline Contracture After the Last Injection
30 days after last treatment
Change From Baseline Range of Motion After the Last Injection
30 days after last treatment
Time to First Achieve and Maintain Clinical Success After the Last Injection
First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months
Study Arms (1)
AK160 0.58 mg
EXPERIMENTALInterventions
AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Aichi, Japan
Unknown Facility
Aomori, Japan
Unknown Facility
Chiba, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Hiroshima, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Ishikawa, Japan
Unknown Facility
Kanagawa, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Mie, Japan
Unknown Facility
Nagano, Japan
Unknown Facility
Nagasaki, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Numakunai, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Tokushima, Japan
Unknown Facility
Tokyo, Japan
Unknown Facility
Yamaguchi, Japan
Related Publications (1)
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.
PMID: 27313184RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Norihiro Tateishi, Manager
- Organization
- XIA Project, Pharmaceuticals Sales Division, Asahi Kasei Pharma Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
April 30, 2012
Study Start
May 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 21, 2017
Results First Posted
February 14, 2017
Record last verified: 2017-02