Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis
NCT ID: NCT02344719
Last Updated: 2015-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2010-10-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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6 capsules Taurin per day
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.
Taurin 6g per day per oral for 28 days
Taurin 6g per day per oral for 28 days
HVPG Measurement baseline
On day 1 (baseline) and day 28 HVPG measurement will be performed
HVPG Measurement day 28
On day 1 (baseline) and day 28 HVPG measurement will be performed
6 capsuless placebo per day
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.
HVPG Measurement baseline
On day 1 (baseline) and day 28 HVPG measurement will be performed
HVPG Measurement day 28
On day 1 (baseline) and day 28 HVPG measurement will be performed
Placebo 6g per day per oral for 28 days
Placebo to Taurin 6g per day per oral for 28 days
Interventions
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Taurin 6g per day per oral for 28 days
Taurin 6g per day per oral for 28 days
HVPG Measurement baseline
On day 1 (baseline) and day 28 HVPG measurement will be performed
HVPG Measurement day 28
On day 1 (baseline) and day 28 HVPG measurement will be performed
Placebo 6g per day per oral for 28 days
Placebo to Taurin 6g per day per oral for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
* Cardiac, renal or respiratory failure
* Previous surgical or transjugular intrahepatic portosystemic shunt
* Breast-feeding or pregnant women
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Arnulf Ferlitsch, MD
Assoz. Prof. Dr.
Principal Investigators
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Arnulf Ferlitsch, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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2010-020880-19
Identifier Type: -
Identifier Source: org_study_id
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