NCT02344719

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

4.6 years

First QC Date

January 12, 2015

Last Update Submit

September 24, 2015

Conditions

CirrhosisPortal Hypertension

Keywords

cirrhosisportal hypertensiontaurin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

6 capsules Taurin per day

ACTIVE COMPARATOR

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 daysProcedure: HVPG Measurement baselineProcedure: HVPG Measurement day 28

6 capsuless placebo per day

PLACEBO COMPARATOR

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 baselineProcedure: HVPG Measurement day 28Drug: Placebo 6g per day per oral for 28 days

Interventions

Taurin 6g per day per oral for 28 daysDRUG

Taurin 6g per day per oral for 28 days

Also known as: Taurin
6 capsules Taurin per day
HVPG Measurement baselinePROCEDURE

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

Also known as: HVPG
6 capsules Taurin per day6 capsuless placebo per day
HVPG Measurement day 28PROCEDURE

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

Also known as: HVPG
6 capsules Taurin per day6 capsuless placebo per day
Placebo 6g per day per oral for 28 daysDRUG

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

6 capsuless placebo per day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Cardiac, renal or respiratory failure
  • Previous surgical or transjugular intrahepatic portosystemic shunt
  • Breast-feeding or pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

FibrosisHypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Arnulf Ferlitsch, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoz. Prof. Dr.

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 26, 2015

Study Start

October 1, 2010

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

AU(1)