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

NCT02488993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 389

Last updated 2018-12-13

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy

Interventions

OTHER

Prospective Phase Rifaximin-α 550mg

Prospective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.

OTHER

Prospective Phase No Rifaximin-α 550mg

Prospective data collection of all patients not receiving rifaximin-α 550 mg from the point of study entry.

OTHER

Retrospective Phase

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.

Sponsors & Collaborators

Principal Investigators

  • Richard Ng · Norgine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-09-29
Completion
2018-09-29

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488993 on ClinicalTrials.gov