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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Portal Hypertension; Cirrhosis

Treatments: Procedure: HVPG Measurement baseline; Drug: Placebo 6g per day per oral for 28 days; Procedure: HVPG Measurement day 28; Drug: Taurin 6g per day per oral for 28 days

Study type: Interventional

Funder types: Other

Identifiers

NCT02344719

2010-020880-19

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

6 capsules Taurin per day

Active Comparator group

Description:

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.

Treatment:

Drug: Taurin 6g per day per oral for 28 days

Procedure: HVPG Measurement day 28

Procedure: HVPG Measurement baseline

6 capsuless placebo per day

Placebo Comparator group

Description:

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.

Treatment:

Procedure: HVPG Measurement day 28

Drug: Placebo 6g per day per oral for 28 days

Procedure: HVPG Measurement baseline