一项比较原发性免疫缺陷患者的生活质量和满意度的研究,这些患者使用两种不同的输送装置皮下注射 Gammanorm® 165 mg/mL:使用泵注射或快速推压
一项随机、交叉研究,比较原发性免疫缺陷患者的生活质量和满意度,这些患者接受皮下注射 Gammanorm® 165 mg/mL,使用两种不同的输送装置:使用泵注射或快速推入
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Freiburg、德国、D-79106
- University Medical Centre Freiburg
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Leipzig、德国、D-04129
- Municipal Hospital "St. Georg"
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Padova、意大利、35128
- Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
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Rome、意大利、00161
- Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
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Campbelltown、澳大利亚、NSW 2560
- CampbelltownHospital
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Canberra、澳大利亚、ACT 2605
- Canberra Hospital
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Birmingham、英国、B15 2GW
- University Hospitals Birmingham
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Cardiff、英国、CF144XW
- University Hospital of Wales
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London、英国、E12ES
- - The Royal London Hospital
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London、英国、NW3 2QG
- The Royal Free
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Oxford、英国、OX3 9DU
- John Radcliff Hospital
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Plymouth、英国、PL6 8DH
- Derriford Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 成年患者(≥ 18 岁)。
- 表现为原发性免疫缺陷。
- 在纳入时已在家中使用自动泵或注射器接受皮下免疫球蛋白注射至少 1 个月。
- 研究者决定在家中通过皮下注射 Gammanorm® 165 mg/mL 来维持免疫球蛋白替代疗法。
- 自由给予患者的书面知情同意书。
- 有生育能力的女性必须在妊娠试验(基于人绒毛膜促性腺激素 [HCG] 的测定)中取得阴性结果,并且需要在研究期间使用可靠的方法进行避孕。
排除标准:
• 参与另一项介入性临床研究并在进入研究前三个月内接受试验性医药产品。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 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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其他:Chrono Super PID 然后是通用注射器 - Gammanorm
根据基于交叉设计随机分配的顺序,每位患者将使用两种研究的输送装置中的每一种接受研究治疗: • Chrono Super PID 然后是 Generic Syringe-Gammanorm |
根据基于交叉设计随机分配的顺序,每位患者将使用两种研究的递送装置中的每一种接受 Gammanorm 的研究治疗: •泵然后是注射器 使用自动、可编程、紧凑型泵(例如 CRONO SUPER PID)可以让患者在不中断活动的情况下保持活动。 患者可以在 2 至 4 个部位(腹部、大腿、上臂、下背部)以高达 40 mL/h 的输注速率同时输注多个部位。 因此,使用注射器快速和手动管理 SCIg 可以通过减少管理时间(同时在 1 或 2 个位置每次注射约 10 分钟)来代表替代方法。 注射由患者自行进行。 输注速度通常为 1 至 2 mL/min。 使用低粘度产品可促进注射
其他名称:
|
其他:通用注射器然后是 Chrono Super PID - Gammanorm
根据基于交叉设计随机分配的顺序,每位患者将使用两种研究的输送装置中的每一种接受研究治疗: • Generic Syringe 然后是 Chrono Super PID-Gammanorm |
根据基于交叉设计随机分配的顺序,每位患者将使用两种研究的输送装置中的每一种接受研究治疗: • 注射器然后泵。 使用自动、可编程、紧凑型泵(例如 CRONO SUPER PID)可以让患者在不中断活动的情况下保持活动。 患者可以在 2 至 4 个部位(腹部、大腿、上臂、下背部)以高达 40 mL/h 的输注速率同时输注多个部位。 因此,使用注射器快速和手动管理 SCIg 可以通过减少管理时间(同时在 1 或 2 个位置每次注射约 10 分钟)来代表替代方法。 注射由患者自行进行。 输注速度通常为 1 至 2 mL/min。 使用低粘度产品可促进注射
其他名称:
|
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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比较通过所用输送装置接受 Gammanorm® 165 mg/mL 皮下注射的 PID 患者的满意度(LQI 问卷,因素 I:治疗干扰)。
大体时间:参与者将被跟踪总共 6 个月
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根据基于交叉设计(注射器然后泵,或泵然后注射器)分配的顺序,每个患者将接受两个连续三个月的治疗,没有任何中间清洗期。
因此,每位患者的研究治疗总持续时间为 6 个月。
评估将通过 LQI 量表进行。
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参与者将被跟踪总共 6 个月
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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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比较其他生活质量分数
大体时间:参与者将被跟踪总共 6 个月
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根据基于交叉设计(注射器然后泵,或泵然后注射器)分配的顺序,每个患者将接受两个连续三个月的治疗,没有任何中间清洗期。 因此,每位患者的研究治疗总持续时间为 6 个月。 将通过 LQI 量表因子 II 和 III 进行评估 患者生活质量将通过 SF-36 量表进行评估。 患者满意度将通过 TSQM-11 量表进行评估 |
参与者将被跟踪总共 6 个月
|
合作者和调查者
赞助
调查人员
- 首席研究员:Klaus Warnatz, MD、Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher
出版物和有用的链接
一般刊物
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