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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344719
• Other study ID #: 2010-020880-19
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2015
• Last updated: September 24, 2015
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

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

Procedure:
• 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

Drug:
• Placebo 6g per day per oral for 28 days
Placebo to Taurin 6g per day per oral for 28 days

Locations

Country	Name	City	State
Austria	Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HVPG change in mmHg after 28 days with Taurin 6g or placebo	To investigate the response to 6g taurine p.o. for 28 days on the hepatic venous pressure gradient	28 days	No