NCT01588353已完成3 期
Phase III Study of AK160 in Patients With Dupuytren's Contracture
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 AK
- •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.
研究组 & 干预措施
AK160 0.58 mg
Experimental
干预措施: Collagenase Clostridium Histolyticum (Drug)
结局指标
主要结局
The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
时间窗: 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.
次要结局
- 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)
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