A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients

Phase 2CompletedNCT00592475

Cumberland Pharmaceuticals20 enrolled

Overview

To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

20

Conditions

Liver Cirrhosis

Interventions

IV

IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and appropriate privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable) * Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis * Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both Exclusion Criteria: * Clinical evidence of volume depletion or dehydration * Subject has a history of bleeding from esophageal varices within three months before the start of the study

Locations (1)

Unnamed facility

Barcelona, Spain

Outcomes

Primary Outcomes

Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose

Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.

Time frame: Baseline and 0.5, 1, and 1.5 hours post dose

Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose

Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.

Time frame: Baseline and 0.5, 1, and 1.5 hours post dose

Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose

Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.

Time frame: Baseline and 0.5, 1, and 1.5 hours post dose

Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose

Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.

Time frame: Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose

Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose

Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.

Time frame: Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose

Secondary Outcomes

Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

NCT00592475 - A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients | Crick | Crick