TrAtaMiEnto deL sIndrOme hepatoRrenAl con TErlipresina en infusión ajustada a la respuesta hemodinámica.

Treatment of hepatorenal syndrome with terlipressin infusion adjusted to hemodynamic response

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002166-20-ES

Enrollment

Unknown

Registered

2012-01-11

Start date

2012-02-08

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatorenal syndrome (HRS) type 1 MedDRA version: 14.1 Level: PT Classification code 10019846 Term: Hepatorenal syndrome System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 14.1 Level: PT Classification code 10019641 Term: Hepatic cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: GLYPRESSIN 1mg polvo y disolvente para solución inyectable Product Name: GLYPRESSIN 1mg polvo y disolvente para solución inyectable Pharmaceutical Form: Concentrate and solvent for solutio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with type 1 HRS. - Signed Informed consent. - No exclusion criteria. - Age> 18 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma having more than 3 nodules, single nodule larger than 5 cm, tumor portal vein thrombosis or extrahepatic tumor spread. - Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension or septic CBC). - Cardiac or respiratory failure clinically significant. - Clinically significant peripheral artery disease. - A history of ischemic heart disease. - Hypersensitivity to terlipressin and / or albumin or any of the excipients. - Pregnancy. - Septic shock. - Chronic renal failure.

Design outcomes

Primary

Measure	Time frame
Main Objective: To observe the effect of terlipressin on renal function in patients with HRS Type 1 by adjusting the dose based on the hemodynamic response;Secondary Objective: - Determine the predictors of response to treatment. - Evaluate the safety and adverse effects.;Primary end point(s): To observe the effect of terlipressin on renal function in patients with HRS Type 1 by adjusting the dose based on the hemodynamic response.;Timepoint(s) of evaluation of this end point: N/A	—

Measure

Time frame

Main Objective: To observe the effect of terlipressin on renal function in patients with HRS Type 1 by adjusting the dose based on the hemodynamic response;Secondary Objective: - Determine the predictors of response to treatment. - Evaluate the safety and adverse effects.;Primary end point(s): To observe the effect of terlipressin on renal function in patients with HRS Type 1 by adjusting the dose based on the hemodynamic response.;Timepoint(s) of evaluation of this end point: N/A

—

Secondary

Measure	Time frame
Secondary end point(s): - Determine the predictors of response to treatment. - Evaluate the safety and adverse effects.;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Spain

Contacts

Public ContactCTU-Clinic. Farmacologia clinica

Fundació clínic per a la Recerca biomèdica

jaarnaiz@clinic.ub.es+349322754004380

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026