NCT04318405已完成不适用
Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 21
- 主要终点
- Attitude of patients towards IV iron treatment evaluated with questionnaire.
研究概览
简要总结
Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.
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
- •Legally capable male and female patients, aged ≥ 18 years (no upper limit);
- •Written informed consent of the patient with regard to the pseudonymized documentation;
- •The patients are not selected by specific inclusion or exclusion criteria, but by the indication listed in the Swiss SmPC (Summary of Product Characteristics) of Monofer®;
- •Decision is taken to treat the patient with IIM in accordance with the current Swiss SmPC of Monofer® and by prescription; this decision is taken prior to and independent from the inclusion into the study.
排除标准
- •Any contraindication regarding IIM treatment as specified in the Swiss SmPC of Monofer®;
- •Retrospective observation of IIM infusion;
- •Current or upcoming participation in an interventional clinical trial;
- •Prior IV iron treatment or transfusion within 3 months prior to enrolment;
- •Instable and/or untreated comorbidities potentially hampering the observation of the primary outcome parameter of this study;
- •Prisoners or persons who are compulsorily detained (involuntarily incarcerated).
结局指标
主要结局
Attitude of patients towards IV iron treatment evaluated with questionnaire.
时间窗: Change from baseline taking into account baseline (BL) and follow-up (FU) answers. Follow-up at the latest 12 weeks after observed dosing and before a potential subsequent dosing (if available based on clinical routine follow-up).
Rate of patients with stability or positive change in attitude. Questionnaire comprises the following questions: 1. I am hesitant to be treated with IV iron. 2. I would consider IV iron treatment due to the physician ́s choice. 3. I would consider IV iron treatment due to its safety compared to other iron treatment options. 4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options.
次要结局
- Reason(s) for selection of IIM.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Treatment with IIM.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Attitude of patients towards IIM treatment evaluated with questionnaire.(Complete observation time-frame (the total observation period of this study will amount to 90 months).)
- Calculation of iron need based on IIM simplified dosing scheme.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Effectiveness of treatment with IIM.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Treatment sequence before IIM.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Treatment satisfaction of physician and patient upon treatment.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Effectiveness of treatment with IIM: serum ferritin increase.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Effectiveness of treatment with IIM: whole blood count changes.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Effectiveness of treatment with IIM: total Hb increase.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Attitude of physicians towards IIM and IV iron treatment evaluated with questionnaire.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Patient and disease profiles at baseline.(Baseline.)
- Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions).(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
- Effectiveness of treatment with IIM: CRP (C-reactive protein) status.(Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).)
研究者
研究点 (21)
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