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

Primary Purpose

Cirrhosis, Portal Hypertension

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Taurin 6g per day per oral for 28 days
HVPG Measurement baseline
HVPG Measurement day 28
Placebo 6g per day per oral for 28 days
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring cirrhosis, portal hypertension, taurin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

6 capsules Taurin per day

6 capsuless placebo per day

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2015
Last Updated
September 24, 2015
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02344719
Brief Title
Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis
Official Title
The Effect of Oral Taurine on Portal Hemodynamics in Patients With Advanced
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators want to analyze the effect of Taurin on portal hemodynamics in patients with advanced liver cirrhosis.
Detailed Description
28 days of 6 grams Taurine versus Placebo (randomization 1:1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Hypertension
Keywords
cirrhosis, portal hypertension, taurin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6 capsules Taurin per day
Arm Type
Active Comparator
Arm Description
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.
Arm Title
6 capsuless placebo per day
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Taurin 6g per day per oral for 28 days
Other Intervention Name(s)
Taurin
Intervention Description
Taurin 6g per day per oral for 28 days
Intervention Type
Procedure
Intervention Name(s)
HVPG Measurement baseline
Other Intervention Name(s)
HVPG
Intervention Description
On day 1 (baseline) and day 28 HVPG measurement will be performed
Intervention Type
Procedure
Intervention Name(s)
HVPG Measurement day 28
Other Intervention Name(s)
HVPG
Intervention Description
On day 1 (baseline) and day 28 HVPG measurement will be performed
Intervention Type
Drug
Intervention Name(s)
Placebo 6g per day per oral for 28 days
Intervention Description
Placebo to Taurin 6g per day per oral for 28 days
Primary Outcome Measure Information:
Title
HVPG change in mmHg after 28 days with Taurin 6g or placebo
Description
To investigate the response to 6g taurine p.o. for 28 days on the hepatic venous pressure gradient
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnulf Ferlitsch, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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