AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
2017年10月26日 更新者：Endo Pharmaceuticals
A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
研究概览
研究类型
介入性
注册 (实际的)
286
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90095
- 100 UCLA Medical Plaza, Suite 305
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Palo Alto、California、美国、94304
- Hand Surgery Clinic
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Colorado
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Denver、Colorado、美国、80210
- Hand Surgery Associates, PC
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Georgia
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Atlanta、Georgia、美国、30342
- The Hand and Upper Extremity Center of Georgia, P.C.
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Illinois
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Rockford、Illinois、美国、61107
- Rockford Orthopedic Associates, Ltd.
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Indiana
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Indianapolis、Indiana、美国、46260
- The Indiana Hand Center
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital, Department of Orthopedic Surgery
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Newton、Massachusetts、美国、02462
- Newton-Wellesley Hospital
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Minnesota
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Minneapolis、Minnesota、美国、55431
- TRIA Orthopaedic Center
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New York
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New York、New York、美国、10021
- Hospital for Special Surgery
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Stony Brook、New York、美国、11794
- SUNY Stony Brook - Department of Orthopedics
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Oklahoma
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Oklahoma City、Oklahoma、美国、73109
- Health Research Institute
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Pennsylvania
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Erie、Pennsylvania、美国、16550
- Hand Microsurgery & Reconstructive Orthopaedics
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State College、Pennsylvania、美国、16801
- University Orthopedics Center
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Rhode Island
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Providence、Rhode Island、美国、02905
- Department of Orthopaedics, Brown University, Rhode Island Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
- Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- Were naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
- Were judged to be in good health.
- Must have participated in protocol AUX-CC-857 (NCT00528606).
Exclusion Criteria:
- Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
- Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：AA4500 0.58 毫克
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Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days.
Individual cords may have received up to a maximum of three AA4500 injections.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reduction in Contracture to 5° or Less
大体时间：Within 30 days after last injection
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Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
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Within 30 days after last injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical Improvement After the Last Injection
大体时间：Baseline, within 30 days after last injection
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Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
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Baseline, within 30 days after last injection
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Percent Reduction From Baseline Contracture After the Last Injection
大体时间：Baseline, Day 30 after last injection
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Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
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Baseline, Day 30 after last injection
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Change From Baseline Range of Motion After the Last Injection
大体时间：Baseline, Day 30 after last injection
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Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
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Baseline, Day 30 after last injection
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Time to Reach Clinical Success
大体时间：Within 30 days after last injection
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Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
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Within 30 days after last injection
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Clinical Success After the First Injection
大体时间：Within 30 days after first injection
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Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
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Within 30 days after first injection
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Clinical Improvement After the First Injection
大体时间：Baseline, within 30 days after first injection
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Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
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Baseline, within 30 days after first injection
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Percent Reduction From Baseline Contracture After the First Injection
大体时间：Baseline, Day 30 after first injection
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Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
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Baseline, Day 30 after first injection
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Change From Baseline Range of Motion After the First Injection
大体时间：Baseline, Day 30 after first injection
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Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
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Baseline, Day 30 after first injection
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Veronica Urdaneta, MD、Endo Pharmaceuticals
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年12月1日
初级完成 (实际的)
2008年11月1日
研究完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2007年9月11日
首先提交符合 QC 标准的
2007年9月11日
首次发布 (估计)
2007年9月12日
研究记录更新
最后更新发布 (实际的)
2017年12月2日
上次提交的符合 QC 标准的更新
2017年10月26日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.