CirrhosisPhase 4NCT02344719
Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis
A Phase 4 study testing Taurin 6g per day per oral for 28 days, HVPG Measurement baseline and HVPG Measurement day 28 in people with Cirrhosis and Portal Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators want to analyze the effect of Taurin on portal hemodynamics in patients with advanced liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Portal Hypertension
- What is being tested?
- Taurin 6g per day per oral for 28 days, HVPG Measurement baseline and HVPG Measurement day 28
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, 1090
About this study
Official title: The Effect of Oral Taurine on Portal Hemodynamics in Patients With Advanced
The investigators want to analyze the effect of Taurin on portal hemodynamics in patients with advanced liver cirrhosis.
Read the detailed description
28 days of 6 grams Taurine versus Placebo (randomization 1:1).
- Conditions
- Cirrhosis, Portal Hypertension
- Being tested
- 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
- Keywords
- cirrhosis, portal hypertension, taurin
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurin 6g per day per oral for 28 daysDrug
Also called Taurin
Taurin 6g per day per oral for 28 days
HVPG Measurement baselineProcedure or surgery
Also called HVPG
On day 1 (baseline) and day 28 HVPG measurement will be performed
HVPG Measurement day 28Procedure or surgery
Also called HVPG
On day 1 (baseline) and day 28 HVPG measurement will be performed
Placebo 6g per day per oral for 28 daysDrug
Placebo to Taurin 6g per day per oral for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Taurin 6g per day per oral for 28 days; Procedure: HVPG Measurement baseline; Procedure: 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. Receives: Procedure: HVPG Measurement baseline; Procedure: HVPG Measurement day 28; Drug: Placebo 6g per day per oral for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startOct 2010
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnulf Ferlitsch, MD, Medical University of Vienna
- Investigators
- Arnulf Ferlitsch, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344719
- Sponsor's protocol ID
- 2010-020880-19
- Status last verified
- Sep 2015
- First submitted
- 12 Jan 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Taurine on Portal Hemodynamics in Patients With Advanced
- ClinicalTrials.gov ID
- NCT02344719
- Acronym / sponsor ID
- 2010-020880-19
- Conditions
- Cirrhosis, Portal Hypertension
- Keywords
- cirrhosis, portal hypertension, taurin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 capsules Taurin per day | Active comparator | Drug: Taurin 6g per day per oral for 28 days, Procedure: HVPG Measurement baseline, Procedure: HVPG Measurement day 28After 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. |
| 6 capsuless placebo per day | Placebo comparator | Procedure: HVPG Measurement baseline, Procedure: HVPG Measurement day 28, Drug: Placebo 6g per day per oral for 28 daysAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurin 6g per day per oral for 28 daysAlso: TaurinTaurin 6g per day per oral for 28 days | Drug | 6 capsules Taurin per day |
| HVPG Measurement baselineAlso: HVPGOn day 1 (baseline) and day 28 HVPG measurement will be performed | Procedure or surgery | 6 capsules Taurin per day, 6 capsuless placebo per day |
| HVPG Measurement day 28Also: HVPGOn day 1 (baseline) and day 28 HVPG measurement will be performed | Procedure or surgery | 6 capsules Taurin per day, 6 capsuless placebo per day |
| Placebo 6g per day per oral for 28 daysPlacebo to Taurin 6g per day per oral for 28 days | Drug | 6 capsuless placebo per day |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnulf Ferlitsch, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Taurin 6g per day per oral for 28 days, HVPG Measurement baseline and HVPG Measurement day 28 in people with Cirrhosis and Portal Hypertension, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HVPG change in mmHg after 28 days with Taurin 6g or placebo (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.