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

Phase 4

Completed

• Conditions: Cirrhosis; Portal Hypertension
• Interventions: Procedure: HVPG Measurement baseline; Drug: Taurin 6g per day per oral for 28 days; Procedure: HVPG Measurement day 28; Drug: Placebo 6g per day per oral for 28 days

• Registration Number: NCT02344719
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 capsules Taurin per day	HVPG Measurement day 28	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.
6 capsuless placebo per day	HVPG Measurement baseline	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.
6 capsuless placebo per day	HVPG Measurement day 28	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.
6 capsuless placebo per day	Placebo 6g per day per oral for 28 days	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.
6 capsules Taurin per day	Taurin 6g per day per oral for 28 days	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.
6 capsules Taurin per day	HVPG Measurement baseline	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.

Primary Outcome Measures

Name	Time	Method
HVPG change in mmHg after 28 days with Taurin 6g or placebo	28 days	To investigate the response to 6g taurine p.o. for 28 days on the hepatic venous pressure gradient

Trial Locations

Locations (1)

Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna; 🇦🇹 Vienna, Austria