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

September 24, 2015 updated by: Arnulf Ferlitsch, MD, Medical University of Vienna

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Taurin 6g per day per oral for 28 days
Taurin 6g per day per oral for 28 days
Other Names:
  • Taurin
Procedure: HVPG Measurement baseline
On day 1 (baseline) and day 28 HVPG measurement will be performed
Other Names:
  • HVPG
Procedure: HVPG Measurement day 28
On day 1 (baseline) and day 28 HVPG measurement will be performed
Other Names:
  • HVPG
Placebo Comparator: 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.
Procedure: HVPG Measurement baseline
On day 1 (baseline) and day 28 HVPG measurement will be performed
Other Names:
  • HVPG
Procedure: HVPG Measurement day 28
On day 1 (baseline) and day 28 HVPG measurement will be performed
Other Names:
  • HVPG
Drug: Placebo 6g per day per oral for 28 days
Placebo to Taurin 6g per day per oral for 28 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Arnulf Ferlitsch, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-020880-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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