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

Liver Cirrhosis Clinical Trial

Official title:

A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Assess the Safety and Effects of Intravenous Conivaptan on the Hepatic Hemodynamic Response in Stable Euvolemic or Hypervolemic Cirrhotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592475
• Other study ID #: 087-CL-089
• Secondary ID: 2007-001661-15
• Status: Completed
• Phase: Phase 2
• First received: January 2, 2008
• Last updated: April 30, 2014
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: April 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Drug:
• conivaptan
IV
• Placebo
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 0.5, 1, and 1.5 hours post dose	No
Primary	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.	Baseline and 0.5, 1, and 1.5 hours post dose	No
Primary	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.	Baseline and 0.5, 1, and 1.5 hours post dose	No
Primary	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.	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	No
Primary	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.	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	No
Secondary	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 serum sodium value is the last measurement prior to dosing.; Change from baseline is calculated as time point minus baseline.	Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose	No

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