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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2015 by Norgine
Sponsor:
Information provided by (Responsible Party):
Norgine
ClinicalTrials.gov Identifier:
NCT02488993
First received: June 15, 2015
Last updated: December 10, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention
Hepatic Encephalopathy Other: Prospective Phase Rifaximin-α 550mg Other: Prospective Phase No Rifaximin-α 550mg Other: Retrospective Phase

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Target Follow-Up Duration: 2 Years
Official Title: PROSPER: Prospective Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin-α (TARGAXAN®/XIFAXAN®) 550 mg

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • All-cause hospitalization rate in patients with HE receiving rifaximin-α 550 mg compared to those receiving other therapies [ Time Frame: 12 months ]
  • Global Evaluation of Treatment Effectiveness of rifaximin-α 550 mg compared to other therapies [ Time Frame: 12 months ]
  • Chronic Liver Disease Questionnaire (CLDQ) to evaluate effectiveness of rifaximin-α 550 mg compared to other therapies [ Time Frame: 12 months ]
  • Number of sublects with adverse events after rifaximin-α 550 mg compared with other therapies [ Time Frame: 12 months ]
  • Work productivity and Activity Impairment Questionnaire to evaluate quality of life in patients with HE [ Time Frame: 12 months ]

Estimated Enrollment: 550
Study Start Date: June 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prospective Phase Rifaximin-α 550mg
Prospective data collection of patients treated with Rifaximin-α 550mg from point of study entry.
Other: Prospective Phase Rifaximin-α 550mg
Prospective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.
Other Names:
  • TARGAXAN
  • XIFAXAN
Prospective Phase No Rifaximin-α 550mg
Prospective data collection of patients NOT treated with Rifaximin-α 550mg from 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.
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.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis aged 18 years or over who are enrolled within 12 weeks of resolution of an episode of overt HE associated with a hospital visit, who are eligible for treatment with rifaximin-α 550 mg.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02488993

Contacts
Contact: Jeff Pilot 01895 453 736 ext 736 jpilot@norgine.com
Contact: Dave Walker 01895 453 654 ext 654 dwalker@norgine.com

Locations
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom
Contact: Andrew Holt         
Sponsors and Collaborators
Norgine
Investigators
Study Director: Richard Ng Norgine
  More Information

Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT02488993     History of Changes
Other Study ID Numbers: ZZ2014GL03
Study First Received: June 15, 2015
Last Updated: December 10, 2015

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 21, 2017