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

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ClinicalTrials.gov Identifier: NCT02488993
Recruitment Status : Unknown
Verified December 2015 by Norgine.
Recruitment status was:  Recruiting
First Posted : July 2, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Norgine

Brief 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.


Condition or disease Intervention/treatment
Hepatic Encephalopathy Other: Prospective Phase Rifaximin-α 550mg Other: Prospective Phase No Rifaximin-α 550mg Other: Retrospective Phase

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 550 participants
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
Study Start Date : June 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Group/Cohort Intervention/treatment
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.




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT02488993     History of Changes
Other Study ID Numbers: ZZ2014GL03
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 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