NCT00954746已完成不适用
CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study
Endo Pharmaceuticals39 个研究点 分布在 6 个国家目标入组 645 人开始时间: 2009年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 645
- 试验地点
- 39
- 主要终点
- Contracture Measurements
研究概览
简要总结
The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.
详细描述
Phase 3 non-treatment study in which Year 2 to Year 5 year follow-up of subjects who received AA4500 in the 9-month open-label studies (AUX-CC-854 and AUX-CC-856) or the 12-month double-blind with open-label extension studies (AUX-CC-857/AUX-CC-858 and AUX-CC-859). After completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for this study a subject had to:
- •Have received at least one injection of AA4500 in one of the Auxilium sponsored studies (AUX-CC-854, AUX-CC-856, Studies AUX-CC-857/AUX-CC-858, or AUX-CC-859) and have at least one fixed-flexion contracture measurement after treatment with AA4500
- •Be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator
- •Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)
排除标准
- 未提供
结局指标
主要结局
Contracture Measurements
时间窗: yearly
次要结局
- Immunogenicity, concomitant medications, medical history, and adverse events(yearly)
研究者
研究点 (39)
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