Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

This study has been suspended.

( because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point. )

First Received: February 3, 2006 Last Updated: April 10, 2007 History of Changes

Sponsors and Collaborators:	Hospital Clinic of Barcelona Grant from Education Ministery from 2001-2004.
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00287664

Purpose

Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.

Condition	Intervention	Phase
Cirrhosis Hepatorenal Syndrome	Drug: terlipressin	Phase IV

MedlinePlus related topics: Cirrhosis

Drug Information available for: Terlipressin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Survival

Estimated Enrollment:	100
Study Start Date:	February 2002
Estimated Study Completion Date:	September 2006

Detailed Description:

Phase 3

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL
Age between 18 and 75 years
Written informed consent.
Absence of exclusion criteria

Exclusion Criteria:

Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
Active infection with systemic inflammatory response syndrome
Respiratory or cardiac dysfunction.
Arteriopathy.
Ischemic cardiopathy.
Arterial hypertension ( >140/90 mmHg during hospitalization )

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287664

Locations

Spain
Hospital Clinic
Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Grant from Education Ministery from 2001-2004.

Investigators

Principal Investigator:

Pere Gines, MD

Chair of Liver Unit

More Information

No publications provided

Study ID Numbers:	TAHRS
Study First Received:	February 3, 2006
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00287664 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:

hepatorenal syndrome
terlipressin
albumin
cirrhosis

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Urologic Diseases
Fibrosis
Terlipressin
Vasoconstrictor Agents

Cardiovascular Agents
Kidney Diseases
Liver Cirrhosis
Antihypertensive Agents
Hepatorenal Syndrome

Additional relevant MeSH terms:

Liver Diseases
Disease
Fibrosis
Liver Cirrhosis
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Digestive System Diseases

Pathologic Processes
Urologic Diseases
Therapeutic Uses
Syndrome
Terlipressin
Vasoconstrictor Agents
Kidney Diseases
Hepatorenal Syndrome

ClinicalTrials.gov processed this record on May 07, 2009