Hepatic EncephalopathyPROSPERNCT02488993

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

An observational study of Hepatic Encephalopathy, run by Norgine at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatic Encephalopathy
What is being tested?: Prospective Phase Rifaximin-α 550mg, Prospective Phase No Rifaximin-α 550mg and Retrospective Phase
How many people: 389 participants
Where: 1 siteUnited Kingdom
Study dates: Jun 2015to 29 Sep 2018
How long will I take part?: 2 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Queen Elizabeth Hospital
Birmingham

Other trials in United Kingdom

About this study

Official title: PROSPER: Prospective Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin-α (TARGAXAN®/XIFAXAN®) 550 mg

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.

Read the 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.

Conditions: Hepatic Encephalopathy
Being tested: Prospective Phase Rifaximin-α 550mg, Prospective Phase No Rifaximin-α 550mg, Retrospective Phase
Medical subject headings: Hepatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prospective Phase Rifaximin-α 550mgOther
Also called TARGAXAN, XIFAXAN
Prospective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.
Prospective Phase No Rifaximin-α 550mgOther
Prospective data collection of all patients not receiving rifaximin-α 550 mg from the point of study entry.
Retrospective PhaseOther
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.

Study groups in NCT02488993
Study group	Role	What they receive
Prospective Phase Rifaximin-α 550mg		Prospective data collection of patients treated with Rifaximin-α 550mg from point of study entry. Receives: 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. Receives: 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. Receives: Other: Retrospective Phase

What is being measured

The primary outcome is the main question the study is designed to answer.

HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies
Measured: 12 months

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201529 Sep 2018

First posted2 Jul 2015 (estimated)
Study startJun 2015
Primary completion29 Sep 2018
Study completion29 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Other
Enrolment: 389 participants (actual)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02488993
Sponsor's protocol ID: ZZ2014GL03
Acronym: PROSPER
Status last verified: Dec 2018
First submitted: 15 Jun 2015
Last updated: 13 Dec 2018
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 37467180
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.
PubMed 30288327

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatic Encephalopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROSPER: Prospective Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin-α (TARGAXAN®/XIFAXAN®) 550 mg
ClinicalTrials.gov ID: NCT02488993
Acronym / sponsor ID: PROSPER / ZZ2014GL03
Conditions: Hepatic Encephalopathy
Study type: Observational
Recruitment status: Completed
Enrolment: 389 participants (actual)
Lead sponsor: NorgineIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: 29 Sep 2018 (actual)
Study completion: 29 Sep 2018 (actual)
First posted: 2 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Case only
Time perspective: Other
Target follow-up: 2 Years
Number of arms: 3

Arm	Type	Receives
Prospective Phase Rifaximin-α 550mg	–	Other: Prospective Phase Rifaximin-α 550mgProspective data collection of patients treated with Rifaximin-α 550mg from point of study entry.
Prospective Phase No Rifaximin-α 550mg	–	Other: Prospective Phase No Rifaximin-α 550mgProspective data collection of patients NOT treated with Rifaximin-α 550mg from point of study entry.
Retrospective Phase	–	Other: Retrospective PhaseReview of medical records and electronic hospital admissions data for patients with HE who have not received Rifaximin-α 550mg within the previous 12 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prospective Phase Rifaximin-α 550mgAlso: TARGAXAN, XIFAXANProspective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.	Other	Prospective Phase Rifaximin-α 550mg
Prospective Phase No Rifaximin-α 550mgProspective data collection of all patients not receiving rifaximin-α 550 mg from the point of study entry.	Other	Prospective Phase No Rifaximin-α 550mg
Retrospective PhaseReview 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	Retrospective Phase

Primary outcome

HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies
Time frame: 12 months

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
Derived from this study: PubMed 37467180Zacharias 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.
Derived from this study: PubMed 30288327Krag 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.

Related trials for Hepatic Encephalopathy

Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
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Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Ng study director

Norgine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatic Encephalopathy, run by Norgine at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HE and liver related hospitalization rate in patients receiving rifaximin- α 550mg compared to other therapies (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02488993, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.