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Completed

NCT Number: NCT02344719

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

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

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Vienna, 1090, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Taurin 6g per day per oral for 28 days

Drug

Taurin 6g per day per oral for 28 days

Other names: Taurin

HVPG Measurement baseline

Procedure

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

Other names: HVPG

HVPG Measurement day 28

Procedure

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

Other names: HVPG

Placebo 6g per day per oral for 28 days

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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