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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
Unnamed facility
Aichi, Japan
Unnamed facility
Aomori, Japan
Unnamed facility
Chiba, Japan
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
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
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
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
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fukuoka, Japan
Unnamed facility
Hiroshima, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Ishikawa, Japan
Unnamed facility
Kanagawa, Japan
Unnamed facility
Kumamoto, Japan
Unnamed facility
Kyoto, Japan
...and 10 more locations
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