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CompletedNCT01588353CORD-JUpdated Mar 21, 2017Results posted

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

A Phase 3 interventional study of Collagenase Clostridium Histolyticum in Dupuytren's Contracture, sponsored by Asahi Kasei Therapeutics Corporation. Completed at 20 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-21.

Sponsored by Asahi Kasei Therapeutics Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
104
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dupuytren's Contracture

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Keywords

  • AK160, collagenase clostridium histolyticum
03

In context

Dupuytren Contracture

81 studies on the registry are indexed under Dupuytren Contracture; 17 are open to participants now.

This study's enrollment of 104 is above the median of 72 across 60 interventional studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

Asahi Kasei Therapeutics Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    AK160 0.58 mg

    Drug: Collagenase Clostridium Histolyticum

Interventions

06

What researchers measure

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.

    Time frame: 30 days after the last injection

Secondary outcomes

  1. Clinical Improvement 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.

    Time frame: 30 days after the last injection

  2. Percent Reduction From Baseline Contracture After the Last Injection

    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.

    Time frame: 30 days after last treatment

  3. Change From Baseline Range of Motion After the Last Injection

    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.

    Time frame: 30 days after last treatment

  4. Time to First Achieve and Maintain Clinical Success After the Last Injection

    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.

    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

07

Results

Posted Feb 14, 2017

Participant flow

104 patients were enrolled, and 102 received AK160. This study proceeded stepwise from Step1 through Step3. First, 6 patients were enrolled in Step1 at the selected study centers, thereafter, 71 and 25 patients were enrolled in Steps2 and3 respectively at all centers. The primary endpoint was determined in 77 participants enrolled in Steps1 and 2.

Step1
Participant flow — Step1
MilestoneAK160 0.58 mg Step1AK160 0.58 mg Step 2AK160 0.58 mg Step3
Started600
Completed600
Not completed000
Step2
Participant flow — Step2
MilestoneAK160 0.58 mg Step1AK160 0.58 mg Step 2AK160 0.58 mg Step3
Started0710
Completed0700
Not completed010
Withdrew: Withdrawal by subject010
Step3
Participant flow — Step3
MilestoneAK160 0.58 mg Step1AK160 0.58 mg Step 2AK160 0.58 mg Step3
Started0025
Completed0023
Not completed002
Withdrew: Adverse event002

Outcome measures

PrimaryThe 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.

Time frame:
30 days after the last injection
Reported as:
Number · % Participants
The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
% ParticipantsAK160 0.58 mg Step 1-2
The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"86
SecondaryClinical Improvement 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.

Time frame:
30 days after the last injection
Reported as:
Number · % Participants
Clinical Improvement After the Last Injection
% ParticipantsPrimary MP JointsPrimary PIP JointsTotal
Clinical Improvement After the Last Injection100 (92.5 to 100.0)90.0 (73.5 to 97.9)96.1 (89.0 to 99.2)
SecondaryPercent Reduction From Baseline Contracture After the Last Injection

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.

Time frame:
30 days after last treatment
Reported as:
Mean · % of change from baseline
Percent Reduction From Baseline Contracture After the Last Injection
% of change from baselinePrimary MP JointsPrimary PIP JointsTotal
Percent Reduction From Baseline Contracture After the Last Injection97.08 ± 7.79182.48 ± 24.67491.39 ± 17.900
SecondaryChange From Baseline Range of Motion After the Last Injection

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.

Time frame:
30 days after last treatment
Reported as:
Mean · Degrees
Change From Baseline Range of Motion After the Last Injection
DegreesPrimary MP JointsPrimary PIP JointsTotal
Change From Baseline Range of Motion After the Last Injection41.6 ± 18.9133.3 ± 17.7338.4 ± 18.79
SecondaryTime to First Achieve and Maintain Clinical Success After the Last Injection

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.

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
Reported as:
Median · Days
Time to First Achieve and Maintain Clinical Success After the Last Injection
DaysPrimary MP JointsPrimary PIP JointsTotal
Time to First Achieve and Maintain Clinical Success After the Last Injection1.0 (1.0 to 28.0)7.0 (1.0 to 92.0)1.0 (1.0 to 30.0)

Adverse events

Collected over Adverse events were investigated from the day of the first injection of the study drug until 360 days after the first injection of the study drug.. Non-serious events are listed at a 5.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AK160 0.58 mg Step 1-3—14/102 (13.7%)100/102 (98%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventAK160 0.58 mg Step 1-3
CataractEye disorders3/102
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/102
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/102
Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/102
Duodenal ulcer perforationGastrointestinal disorders1/102
Intestinal obstructionGastrointestinal disorders1/102
Infectious pleural effusionInfections and infestations1/102
Bile duct stoneHepatobiliary disorders1/102
SpondylolysisMusculoskeletal and connective tissue disorders1/102
Idiopathic thrombocytopenic purpuraBlood and lymphatic system disorders1/102
Most frequent other events
Showing 10 of 14
Most frequent other events
EventAK160 0.58 mg Step 1-3
Injection site painGeneral disorders78/102
Injection site bruisingGeneral disorders46/102
Injection site swellingGeneral disorders35/102
ContusionInjury, poisoning and procedural complications30/102
Injection site lacerationGeneral disorders16/102
NasopharyngitisInfections and infestations16/102
Injection site oedemaGeneral disorders12/102
Injection site haematomaGeneral disorders11/102
Local swellingGeneral disorders9/102
LacerationInjury, poisoning and procedural complications9/102

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)AK160 0.58 mg Step 1AK160 0.58 mg Step 2AK160 0.58 mg Step3Total
<=18 years0000
Between 18 and 65 years222226
>=65 years4492376
Age, Continuous
Age, Continuous(years)AK160 0.58 mg Step 1AK160 0.58 mg Step 2AK160 0.58 mg Step3Total
Mean69 ± 8.368 ± 8.471 ± 5.968.7 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)AK160 0.58 mg Step 1AK160 0.58 mg Step 2AK160 0.58 mg Step3Total
Female16310
Male5652292
Region of Enrollment
Region of Enrollment(participants)AK160 0.58 mg Step 1AK160 0.58 mg Step 2AK160 0.58 mg Step3Total
Japan67125102
08

Study locations

20 sites
  • Aichi, Japan
  • Aomori, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Hiroshima, Japan
  • Hokkaido, Japan
  • Ishikawa, Japan
  • Kanagawa, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Mie, Japan
  • Nagano, Japan
  • Nagasaki, Japan
  • Niigata, Japan
  • Numakunai, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Tokushima, Japan
  • Tokyo, Japan
  • Yamaguchi, Japan
09

References and documents

Publications

  • 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. PubMed 27313184 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01588353
Lead sponsor
Asahi Kasei Therapeutics Corporation
Responsible party
Sponsor
First posted
Apr 30, 2012
Start date
May 2012
Primary completion
Jan 2014
Completion
Jan 2014
Results posted
Feb 14, 2017
Last update
Mar 21, 2017
View the source record on ClinicalTrials.gov ↗

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