Feraccru® Real World Effectiveness Study in Hospital Practice (FRESH): A Real World Study to Describe the Outcomes Associated With the Use of Ferric Maltol (Feraccru) for the Management of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease in the UK.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.
研究概览
简要总结
The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability.
详细描述
The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability. By describing the characteristics of patients treated with Feraccru® and their outcomes, this study will provide the medical community with important information to support treatment decisions for their patients. This will ultimately support improvements to patient care, including the long-term outcomes of patients with IBD and IDA
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥ 18 years at the time of initiation .
- •Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and <13.0 g/dL in males, or Hb ≥9.5 g/dL and <12.0 g/dL in females
- •Serum ferritin concentration <30 microgram/L or transferrin saturation of <20% .
- •Patient receiving Feraccru® since the time of UK launch in June 2016.
排除标准
- •Patient receiving Feraccru® as part of an interventional clinical trial.
- •Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®.
- •Patient with an IBD flare, as determined by the clinician.
- •Patient with medical records that are not available for review.
- •Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period
结局指标
主要结局
The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.
时间窗: 12 weeks (permitting 10-16 weeks)
Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.
次要结局
- Time From Diagnosis of IBD to Initiation of Feraccru(Baseline)
- Time From Diagnosis of IDA to Initiation of Feraccru®(Baseline)
- Time to Normalisation of Hb Levels(Baseline to 12 weeks (permitting 10-16 weeks))
- Change in Serum Ferritin Levels at Week 4(Baseline to Week 4 (permitting 3 to 5 weeks))
- Reason for Initiating Feraccru®(Baseline)
- Change in Hb Levels at 12 Weeks(Baseline to Week 12 (permitting 10-16 weeks))
- Percentage of Patients With Normalised Ferritin Levels at 12 Weeks(Baseline to Week 12 (permitting 10-16 weeks))
- Percentage of Patients Who Discontinue Feraccru®(Baseline to week 12)
- Change in Hb Levels at Week 4(Baseline to Week 4 (permitting 3 to 5 weeks))
- Change in Transferrin Saturation at Week 12(Baseline to Week 12)
- Reason for Discontinuing Feraccru®(Baseline to week 12)
- Change in Transferrin Saturation at Week 4(Baseline to Week 4 (permitting 3 to 5 weeks))
- Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®(Baseline to Week 12)
- Prior IV Treatment History(Baseline)
- Reason for Discontinuing Each Prior Oral Ferrous Product(Baseline)
- Change in Serum Ferritin Levels at Week 12(Baseline to Week 12 (permitting 10-16 weeks))
- Time to Correction of Serum Ferritin Levels(Baseline to Week 12 (permitting 10 to 16 weeks))
- Time to Correction of Transferrin Saturation(Baseline to Week 12)
- Adverse Events That Are Related to and Caused by Feraccru®(For the duration of study, average of 12 weeks.)