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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02344719
Other study ID # 2010-020880-19
Secondary ID
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


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
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