A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren’s Contracture

Auxilium Pharmaceuticals, Inc.0 个研究点目标入组 240 人开始时间: 2007年4月20日最近更新: 2020年1月13日

适应症

试验速览

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•1. Subjects must have a diagnosis of Dupuytren’s contracture with a fixed-flexion (ie, = 20º but = 80º for PIP joint; = 20º but = 100º for MP joint) deformity of the finger that is caused by a palpable cord 2. Subject must have a positive table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. 3. Subject is judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile. 4. Subject voluntarily signs and dates an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). 5. Female subjects of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study. A pregnancy test will be performed prior to enrollment in the study.

•1. Female subjects who are nursing or pregnant, or plan to become pregnant during the treatment phase.2. Subject has received an investigational drug within 30 days prior to the first dose of study drug.3. Subject has received treatment for Dupuytren’s contracture within 90 days of enrollment on the joint selected for the initial injection of AA4500. Treatment for Dupuytren’s contracture includes surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.4. Subject has a known allergy to collagenase or any other excipient of AA4500.5. Subject has received doxycycline or doxycycline derivative during the 14 days prior to the first dose of study drug.6. Subject has received any collagenase treatments within 30 days.7. Subject is receiving anticoagulant medication or has received anticoagulant medication (except for aspirin = 150 mg daily) within 7 days before the first injection.8. Subject has a known recent history of stroke, bleeding, or other medical condition which in the investigator’s opinion would make the subject unsuitable for enrollment in the study.

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