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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK160 0.58 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum | Drug | AK160 (Collagenase Clostridium Histolyticum) 0.58 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after the last injection |
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Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27313184 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AK160 0.58 mg Step1 | This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2. And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step1 |
|
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| 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. | 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. | 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. | First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months |
| 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 |
| FG001 | AK160 0.58 mg Step 2 | This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints. |
| FG002 | AK160 0.58 mg Step3 | The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3. This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints. |
| COMPLETED |
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| NOT COMPLETED |
|
| Step2 |
|
|
| Step3 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AK160 0.58 mg Step 1 | This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2. And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints. |
| BG001 | AK160 0.58 mg Step 2 | This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints. |
| BG002 | AK160 0.58 mg Step3 | The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3. This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2. | Posted | Number | % Participants | 30 days after the last injection |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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. | The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2. | Posted | Number | 95% Confidence Interval | % Participants | 30 days after the last injection |
| |||||||||||||||||||||||||||
| Secondary | 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. | The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2. | Posted | Mean | Standard Deviation | % of change from baseline | 30 days after last treatment |
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| Secondary | 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. | The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2. | Posted | Mean | Standard Deviation | Degrees | 30 days after last treatment |
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| ||||||||||||||||||||||||||
| Secondary | 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. | The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2. | Posted | Median | Inter-Quartile Range | Days | First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AK160 0.58 mg Step 1-3 | Collagenase Clostridium Histolyticum: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg | 14 | 102 | 100 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Spondylolysis | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (16.1) | All were determined by investigators to be not related to the study drug. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (16.1) |
| ||
| Injection site bruising | General disorders | MedDRA (16.1) |
| ||
| Injection site swelling | General disorders | MedDRA (16.1) |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.1) |
| ||
| Injection site laceration | General disorders | MedDRA (16.1) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) |
| ||
| Injection site oedema | General disorders | MedDRA (16.1) |
| ||
| Injection site haematoma | General disorders | MedDRA (16.1) |
| ||
| Local swelling | General disorders | MedDRA (16.1) |
| ||
| Laceration | Injury, poisoning and procedural complications | MedDRA (16.1) |
| ||
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (16.1) |
| ||
| Injection site pruritus | General disorders | MedDRA (16.1) |
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| Glucose urine present | Investigations | MedDRA (16.1) |
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| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (16.1) |
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Asahi Kasei Pharma Corporation agreements may vary with individual facilities but will not prohibit any investigator from publishing. Asahikasei supports the publication of results from all centers of a multicenter trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Norihiro Tateishi, Manager | XIA Project, Pharmaceuticals Sales Division, Asahi Kasei Pharma Corporation | +81-3-3296-3641 | xia_project@om.asahi-kasei.co.jp |
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| C570746 | xiapex |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
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| Counts |
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| Participants |
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| Participants |
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