Dupuytren's ContracturePhase 3CORD-JNCT01588353
Collagenase Option for Reduction of Dupuytren's Contracture in Japan
A Phase 3 study testing Collagenase Clostridium Histolyticum in people with Dupuytren's Contracture, run by Asahi Kasei Therapeutics Corporation at 20 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dupuytren's Contracture
- What is being tested?
- Collagenase Clostridium Histolyticum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 20 sitesJapan
- Study dates
- May 2012to Jan 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Study site
Aichi
Study site
Aomori
Study site
Chiba
Study site
Fukuoka
Study site
Hiroshima
Study site
Hokkaido
Study site
Ishikawa
Study site
Kanagawa
Study site
Kumamoto
Study site
Kyoto
Study site
Mie
Study site
Nagano
Study site
Nagasaki
Study site
Niigata
Study site
Numakunai
Study site
Okayama
Study site
Osaka
Study site
Tokushima
Study site
Tokyo
Study site
Yamaguchi
About this study
Official title: Phase III Study of AK160 in Patients With Dupuytren's Contracture
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.
- Conditions
- Dupuytren's Contracture
- Being tested
- Collagenase Clostridium Histolyticum
- Keywords
- AK160, collagenase clostridium histolyticum
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium HistolyticumDrug
Also called Xiaflex® (US), Xiapex® (EU)
AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
| Study group | Role | What they receive |
|---|---|---|
| AK160 0.58 mg | Experimental | Not described Receives: Drug: Collagenase Clostridium Histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the last injection
Secondary outcomes (4)
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.
Measured: 30 days after the last injection
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.
Measured: 30 days after last treatment
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.
Measured: 30 days after last treatment
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.
Measured: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren's ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588353
- Sponsor's protocol ID
- AK160-III-1
- Acronym
- CORD-J
- Status last verified
- Feb 2017
- First submitted
- 27 Apr 2012
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of AK160 in Patients With Dupuytren's Contracture
- ClinicalTrials.gov ID
- NCT01588353
- Acronym / sponsor ID
- CORD-J / AK160-III-1
- Conditions
- Dupuytren's Contracture
- Keywords
- AK160, collagenase clostridium histolyticum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Posted 14 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK160 0.58 mg | Experimental | Drug: Collagenase Clostridium Histolyticum |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase Clostridium HistolyticumAlso: Xiaflex® (US), Xiapex® (EU)AK160 (Collagenase Clostridium Histolyticum) 0.58 mg | Drug | AK160 0.58 mg |
Primary outcome
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.
4 secondary outcomes
Clinical Improvement After the Last Injection
Time frame: 30 days after the last injection
Percent Reduction From Baseline Contracture After the Last Injection
Time frame: 30 days after last treatment
Change From Baseline Range of Motion After the Last Injection
Time frame: 30 days after last treatment
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27313184Hirata 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collagenase Clostridium Histolyticum in people with Dupuytren's Contracture, run by Asahi Kasei Therapeutics Corporation at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.