Retreatment of recurrent contractures in joints effectively treated with AA4500 (collagenase clostridium histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe. - AA4500 Re-treatment Study

Auxilium UK Limited0 个研究点目标入组 52 人开始时间: 2012年2月27日最近更新: 2019年2月28日

试验速览

暂无简介。

•To qualify for the study a subject must:
•1. Provide written informed consent
•2. Be currently participating in the AUX-CC-860 follow-up study
•3. Have at least one joint with all of the following:
•The joint was effectively treated (had a correction to 5° or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
•The effectively treated joint has an increase in contracture of at least 20°compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
•A palpable cord is present in the joint to be treated
•4. Be able to comply with the study visit schedule as specified in the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•A subject will be excluded from study participation if he/she:
•1. Is a pregnant or lactating female or female intending to become pregnant during the study
•2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
•3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for = 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs [NSAIDs]) within 7 days before injection of AA4500

发起方

Auxilium UK Limited