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A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

2017年9月7日 更新者：Endo Pharmaceuticals

A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of a Single Injection of AA4500 0.58 mg in Subjects With Dupuytren's Contracture

A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection.

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

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

16

阶段

  • 阶段1

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

  • 美国
    • California
      • Burbank、California、美国、91505
        • Providence Clinical Research

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 Dupuytren's contracture, 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 naive to AA4500 treatment.
  • Were judged to be in good health.

Exclusion Criteria:

  • Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
  • Had received treatment for Dupuytren's contracture within 90 days of the AA4500 injection to the MP or PIP selected, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
  • 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：其他
  • 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
实验性的：AA4500 0.58 毫克
生物：collagenase clostridium histolyticum
Single dose of AA4500 0.58 mg into the cord
其他名称：
  • 夏弗莱克斯®
  • AA4500

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
Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500
大体时间：Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30
AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).
Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30

次要结果测量

结果测量
措施说明
大体时间
Clinical Success
大体时间：30 days after treatment to the primary joint
Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.
30 days after treatment to the primary joint
Clinical Improvement
大体时间：30 days after treatment to the primary joint
Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined.
30 days after treatment to the primary joint
Percent Change From Baseline Contracture
大体时间：Baseline, 30 days after treatment to the primary joint
Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture.
Baseline, 30 days after treatment to the primary joint
Change From Baseline Range of Motion
大体时间：Baseline, 30 days after treatment to the primary joint
Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees
Baseline, 30 days after treatment to the primary joint

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。

赞助

Endo Pharmaceuticals

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。

有用的网址

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

2007年9月1日

初级完成 (实际的)

2007年12月1日

研究完成 (实际的)

2008年3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10月5日

上次提交的符合 QC 标准的更新

2017年9月7日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AUX-CC-855

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.

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