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Prevention study for Hepatic Encephalopathy
Official title Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
ClinicalTrials.gov ID: NCT04073290
What this study is testing
What is Rifaximin 550 milligram Oral Tablet [XIFAXAN]?
Rifaximin 550 milligram Oral Tablet [XIFAXAN] is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hepatic encephalopathy.
Also referred to as TARGAXAN.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Elective TIPS placement for refractory ascites or recurrent variceal bleeding: Recurrent tense ascites and one or more of the following criteria: i...
- Age ≥18 years
- Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
- Signed informed consent
You likely can't join if
- Any absolute contraindications for TIPS placement
- Use of ciclosporin
- Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
- Age \> 80 years
- Non-cirrhotic portal hypertension
- Portal vein thrombosis (main trunk)
See the full eligibility criteria
- Elective TIPS placement for refractory ascites or recurrent variceal bleeding: Recurrent tense ascites and one or more of the following criteria: i. Not responding to the maximal dose of diuretics (400 milligram...
- Age ≥18 years
- Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
- Signed informed consent
- Any absolute contraindications for TIPS placement
- Use of ciclosporin
- Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
- Age \> 80 years
- Non-cirrhotic portal hypertension
- Portal vein thrombosis (main trunk)
- Current or recent (\<3 months) use of rifaximin
- Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease
- Pregnant or breastfeeding women
- Patients refusing or unable to sign informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Amsterdam, Netherlands
- Groningen, Netherlands
- Leiden, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Amsterdam, Netherlands; Groningen, Netherlands; Leiden, Netherlands; Nijmegen, Netherlands; Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.