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

NCT02488993 | Completed

• 1 other identifier: ZZ2014GL03
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies

  12 months

Secondary Outcomes (5)

• All-cause hospitalization rate in patients with HE receiving rifaximin-α 550 mg compared to those receiving other therapies

  12 months

• Global Evaluation of Treatment Effectiveness of rifaximin-α 550 mg compared to other therapies

  12 months

• Chronic Liver Disease Questionnaire (CLDQ) to evaluate effectiveness of rifaximin-α 550 mg compared to other therapies

  12 months

• Number of sublects with adverse events after rifaximin-α 550 mg compared with other therapies

  12 months

• Work productivity and Activity Impairment Questionnaire to evaluate quality of life in patients with HE

  12 months

Study Arms (3)

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 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

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

Interventions

Prospective Phase Rifaximin-α 550mg OTHER

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

Also known as: TARGAXAN, XIFAXAN

Prospective Phase Rifaximin-α 550mg

Prospective Phase No Rifaximin-α 550mg OTHER

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

Prospective Phase No Rifaximin-α 550mg

Retrospective Phase OTHER

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.

Retrospective Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37467180 DERIVED

• 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.

  PMID: 30288327 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Richard Ng

  Norgine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: September 29, 2018
• Study Completion: September 29, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

GB (1)