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

Hepatic Encephalopathy Clinical Trial

— PROSPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488993
• Other study ID #: ZZ2014GL03
• Status: Completed
• Start date: June 2015
• Est. completion date: September 29, 2018

Study information

• Verified date: December 2018
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: September 29, 2018
• Est. primary completion date: September 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a 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-a as per local summary of product characteristics

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Other:
• Prospective Phase Rifaximin-a 550mg
Prospective data collection of all patients receiving rifaximin-a 550 mg from the point of study entry.
• Prospective Phase No Rifaximin-a 550mg
Prospective data collection of all patients not receiving rifaximin-a 550 mg from the point of study entry.
• Retrospective Phase
Review of medical records and electronic hospital admissions data for patients with HE who have not received rifaximin-a 550 mg during the previous 12 months.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HE and liver related hospitalization rate in patients receiving rifaximin- a 550mg compared to other therapies		12 months
Secondary	All-cause hospitalization rate in patients with HE receiving rifaximin-a 550 mg compared to those receiving other therapies		12 months
Secondary	Global Evaluation of Treatment Effectiveness of rifaximin-a 550 mg compared to other therapies		12 months
Secondary	Chronic Liver Disease Questionnaire (CLDQ) to evaluate effectiveness of rifaximin-a 550 mg compared to other therapies		12 months
Secondary	Number of sublects with adverse events after rifaximin-a 550 mg compared with other therapies		12 months
Secondary	Work productivity and Activity Impairment Questionnaire to evaluate quality of life in patients with HE		12 months