Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin (PROSPER)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PROSPER: Prospective Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin-α (TARGAXAN®/XIFAXAN®) 550 mg

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Other: Prospective Phase Rifaximin-α 550mg
* Other: Prospective Phase No Rifaximin-α 550mg
* Other: Retrospective Phase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Phase Rifaximin-α 550mg<br>Prospective data collection of patients treated with Rifaximin-α 550mg from point of study entry. | Other: Prospective Phase Rifaximin-α 550mg<br>* Prospective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.<br>* Other names: XIFAXAN;|
| Prospective Phase No Rifaximin-α 550mg<br>Prospective data collection of patients NOT treated with Rifaximin-α 550mg from point of study entry. | Other: Prospective Phase No Rifaximin-α 550mg<br>* Prospective data collection of all patients not receiving rifaximin-α 550 mg from the point of study entry.<br>|
| Retrospective Phase<br>Review of medical records and electronic hospital admissions data for patients with HE who have not received Rifaximin-α 550mg within the previous 12 months. | Other: Retrospective Phase<br>* Review of medical records and electronic hospital admissions data for patients with HE who have not received rifaximin-α 550 mg during the previous 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause hospitalization rate in patients with HE receiving rifaximin-α 550 mg compared to those receiving other therapies |  | 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 | 
| 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 |