Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin (PROSPER)
NCT ID: NCT02488993
Last Updated: 2018-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
389 participants
OBSERVATIONAL
2015-06-30
2018-09-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prospective Phase Rifaximin-α 550mg
Prospective data collection of patients treated with Rifaximin-α 550mg from point of study entry.
Prospective Phase Rifaximin-α 550mg
Prospective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.
Prospective Phase No Rifaximin-α 550mg
Prospective data collection of patients NOT treated with Rifaximin-α 550mg from point of study entry.
Prospective Phase No Rifaximin-α 550mg
Prospective data collection of all patients not receiving rifaximin-α 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-α 550mg within the previous 12 months.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prospective Phase Rifaximin-α 550mg
Prospective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.
Prospective Phase No Rifaximin-α 550mg
Prospective data collection of all patients not receiving rifaximin-α 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-α 550 mg during the previous 12 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Norgine
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Ng
Role: STUDY_DIRECTOR
Norgine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
Krag A, Schuchmann M, Sodatonou H, Pilot J, Whitehouse J, Strasser SI, Hudson M. Design of the Prospective Real-world Outcomes Study of hepatic encephalopathy Patients' Experience on Rifaximin-alpha (PROSPER): an observational study among 550 patients. Hepatol Med Policy. 2018 Jan 8;3:4. doi: 10.1186/s41124-017-0029-9. eCollection 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZZ2014GL03
Identifier Type: -
Identifier Source: org_study_id