Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study

Status

Suspended

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00287664

Enrollment

100

Registered

2006-02-07

Start date

2002-02-28

Completion date

2006-09-30

Last updated

2007-04-11

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

Conditions

Cirrhosis, Hepatorenal Syndrome

Keywords

hepatorenal syndrome, terlipressin, albumin, cirrhosis

Brief summary

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.

Detailed description

Phase 3

Interventions

DRUGterlipressin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patients with HRS type 1 or 2 with serum creatinine \>2 mg/dL 2. Age between 18 and 75 years 3. Written informed consent. 4. Absence of

Design outcomes

Primary

Measure	Time frame
Survival	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026