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

Phase 2

Completed

• Conditions: Liver Cirrhosis
• Interventions: Drug: conivaptan; Drug: Placebo

• Registration Number: NCT00592475
• Lead Sponsor: Cumberland Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-14
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2010-05-24
• Results First Submitted QC: 2010-09-08
• Results First Posted: 2010-09-28
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen 2 Conivaptan 25 mg	conivaptan	Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
Regimen 1 Conivaptan 12.5 mg	conivaptan	Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
Regimen 3 Placebo	Placebo	Placebo continuous intravenous infusion over 6.5 hours

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 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.
Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 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.
Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 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.
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	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 is calculated as time point minus baseline.; Baseline procedures were performed prior to study drug administration.
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	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 is calculated as time point minus baseline.; Baseline procedures were performed prior to study drug administration.

Secondary Outcome Measures

Name	Time	Method
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	Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose	Baseline serum sodium value is the last measurement prior to dosing.; Change from baseline is calculated as time point minus baseline.