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

NCT ID: NCT02344719

Last Updated: 2015-09-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-06-30

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).

Conditions

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Cirrhosis Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type ACTIVE_COMPARATOR

Taurin 6g per day per oral for 28 days

Intervention Type DRUG

Taurin 6g per day per oral for 28 days

HVPG Measurement baseline

Intervention Type PROCEDURE

On day 1 (baseline) and day 28 HVPG measurement will be performed

HVPG Measurement day 28

Intervention Type PROCEDURE

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.

Group Type PLACEBO_COMPARATOR

HVPG Measurement baseline

Intervention Type PROCEDURE

On day 1 (baseline) and day 28 HVPG measurement will be performed

HVPG Measurement day 28

Intervention Type PROCEDURE

On day 1 (baseline) and day 28 HVPG measurement will be performed

Placebo 6g per day per oral for 28 days

Intervention Type DRUG

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

Intervention Type DRUG

HVPG Measurement baseline

On day 1 (baseline) and day 28 HVPG measurement will be performed

Intervention Type PROCEDURE

HVPG Measurement day 28

On day 1 (baseline) and day 28 HVPG measurement will be performed

Intervention Type PROCEDURE

Placebo 6g per day per oral for 28 days

Placebo to Taurin 6g per day per oral for 28 days

Intervention Type DRUG

Other Intervention Names

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Taurin HVPG HVPG

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
* Cardiac, renal or respiratory failure
* Previous surgical or transjugular intrahepatic portosystemic shunt
* Breast-feeding or pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Arnulf Ferlitsch, MD

Assoz. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Austria

Other Identifiers

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2010-020880-19

Identifier Type: -

Identifier Source: org_study_id

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