PROSPER: Prospective Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin-α (TARGAXAN®/XIFAXAN®) 550 mg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 389
- 试验地点
- 1
- 主要终点
- HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies
研究概览
简要总结
This study evaluates hepatic encephalopathy (HE) and liver-related hospitalization rates and duration of stay in patients with HE treated with rifaximin-α 550mg compared to patients receiving other therapies.
This registry study aims to comprehensively and rigorously characterize the impact of rifaximin-α 550 mg on hospitalization, clinical safety and effectiveness outcomes, and quality of life in patients with HE in Europe and Australasia.
详细描述
Whilst clinical trial data and a few small observational studies have demonstrated the potential of rifaximin-α 550 mg to reduce overt HE episodes and hospitalizations, there is a need by physicians, commissioners and other healthcare professionals caring for patients with HE to understand the impact of management with rifaximin-α 550 mg on healthcare resource use in real world clinical practice. Currently available data are from evaluations undertaken in single UK centres. In addition, the overall burden of HE has not been well characterized, including the impact on patient quality of life, or impaired productivity incurred by patients' caregivers. This multinational, multicentre disease registry study aims to comprehensively and rigorously characterize the impact of rifaximin-α 550 mg on hospitalization, clinical safety and effectiveness outcomes, and quality of life in patients with HE in Europe and Australasia. The study will expand upon previous work in the following ways:
- Provide characterization of the burden of HE and the impact of rifaximin-α 550 mg in a real world setting, to complement RCT evidence;
- Allow for more rigorous characterization of the impact of rifaximin-α 550 mg on patient outcomes for individuals with HE over time. This will be achieved by prospectively enrolling patients not taking rifaximin-α 550 mg to characterize outcomes over time in the absence of treatment, and by assessing the quality of life and workplace productivity implications of HE.
There will be no change to the management of patients for the purposes of this study beyond normal clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Diagnosis of cirrhosis;
- •Patient is ≥18 years of age;
- •Patient is enrolled within 12 weeks of resolution of an episode of overt HE associated with a hospital visit;
- •Patient is able to provide informed consent to participate in the study (individually or via caregiver);
- •Patient meets clinical eligibility to receive rifaximin-α 550 mg in the opinion of the participating physician, regardless of HE treatment actually received.
排除标准
- •West Haven Conn score of ≥2 at time of study entry (i.e. at provision of informed consent);
- •Mental health disorder such as dementia or psychosis which makes diagnoses of HE questionable;
- •Prior treatment with rifaximin in the 12 months before qualifying episode of overt HE associated with a hospital visit;
- •Contraindications to the use of rifaximin-α as per local summary of product characteristics
结局指标
主要结局
HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies
时间窗: 12 months
次要结局
- All-cause hospitalization rate in patients with HE receiving rifaximin-α 550 mg compared to those receiving other therapies(12 months)
- Number of sublects with adverse events after rifaximin-α 550 mg compared with other therapies(12 months)
- Work productivity and Activity Impairment Questionnaire to evaluate quality of life in patients with HE(12 months)
- Global Evaluation of Treatment Effectiveness of rifaximin-α 550 mg compared to other therapies(12 months)
- Chronic Liver Disease Questionnaire (CLDQ) to evaluate effectiveness of rifaximin-α 550 mg compared to other therapies(12 months)