Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis

Study Overview
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Brief Summary
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The investigators want to analyze the effect of Taurin on portal hemodynamics in patients with advanced liver cirrhosis.

Detailed Description
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28 days of 6 grams Taurine versus Placebo (randomization 1:1).

Official Title
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The Effect of Oral Taurine on Portal Hemodynamics in Patients With Advanced

Conditions
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Cirrhosis, Portal Hypertension

Intervention / Treatment
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* Drug: Taurin 6g per day per oral for 28 days
* Procedure: HVPG Measurement baseline
* Procedure: HVPG Measurement day 28
* Drug: Placebo 6g per day per oral for 28 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (male and female) aged older than 18 years with advanced liver cirrhosis (Child's Grade B and Child's Grade C), regardless of the disease origin (viral, alcoholic, idiopathic), who are scheduled for hepatic hemodynamic investigation Negative pregnancy test of women with childbearing potential Patient without beta blocker therapy: due to: intolerance of the medication, preexisting contraindication against beta blocker therapy, endoscopic band ligation as prophylaxis Exclusion Criteria: History of variceal bleeding without endoscopic band ligation History of endoscopically diagnosed large varices with red spots without previous bleeding and without endoscopic band ligation HVPG < 10 mmHg HVPG > 20 mmHg and varices, unless ligated and treated in an eradication program within 6 months Beta Blocker therapy History of hypersensitivity to the trial drugs and contrast agent or to drugs with similar chemical structure Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systematic antibiotics one week before the study Exclusion criteria for hepatic hemodynamic investigation Cardiac, renal or respiratory failure Previous surgical or transjugular intrahepatic portosystemic shunt Breast-feeding or pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 capsules Taurin per day<br>After baseline HVPG (Hepatic Venous Pressure Measurement)patients take 6x1g capsules of GMP produced Taurin per day, on day 28, after intake of the 6x1g Taurin capsules, HVPG measurement will be repeated. | Drug: Taurin 6g per day per oral for 28 days<br>* Taurin 6g per day per oral for 28 days<br>* Other names: Taurin;Procedure: HVPG Measurement baseline<br>* On day 1 (baseline) and day 28 HVPG measurement will be performed<br>* Other names: HVPG;Procedure: HVPG Measurement day 28<br>* On day 1 (baseline) and day 28 HVPG measurement will be performed<br>* Other names: HVPG;|
| Placebo Comparator: 6 capsuless placebo per day<br>After baseline HVPG measurement patients take 6x1g capsules of placebo per day, on day 28, after intake of the 6x1g placebo capsules, HVPG measurement will be repeated. | Procedure: HVPG Measurement baseline<br>* On day 1 (baseline) and day 28 HVPG measurement will be performed<br>* Other names: HVPG;Procedure: HVPG Measurement day 28<br>* On day 1 (baseline) and day 28 HVPG measurement will be performed<br>* Other names: HVPG;Drug: Placebo 6g per day per oral for 28 days<br>* Placebo to Taurin 6g per day per oral for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HVPG change in mmHg after 28 days with Taurin 6g or placebo | To investigate the response to 6g taurine p.o. for 28 days on the hepatic venous pressure gradient | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, portal hypertension, taurin