Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00287664
• Other study ID #: TAHRS
• Status: Suspended
• Phase: Phase 4
• First received: February 3, 2006
• Last updated: April 10, 2007
• Start date: February 2002
• Est. completion date: September 2006

Study information

• Verified date: April 2007
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

Phase 3

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 exclusion criteria

Exclusion Criteria:

1. Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)

2. Active infection with systemic inflammatory response syndrome

3. Respiratory or cardiac dysfunction.

4. Arteriopathy.

5. Ischemic cardiopathy.

6. Arterial hypertension ( >140/90 mmHg during hospitalization )

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Hepatorenal Syndrome
• Liver Cirrhosis
• Syndrome

Intervention

Drug:
• terlipressin

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Grant from Education Ministery from 2001-2004.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival