Back to resultsA Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
Primary Purpose
Liver Cirrhosis
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
conivaptan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring conivaptan, Liver Cirrhosis, Hypertension, Portal
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Regimen 1 Conivaptan 12.5 mg
Regimen 2 Conivaptan 25 mg
Regimen 3 Placebo
Arm Description
Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
Placebo continuous intravenous infusion over 6.5 hours
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00592475
First Posted
January 2, 2008
Last Updated
April 30, 2014
Sponsor
Cumberland Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00592475
Brief Title
A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cumberland Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
conivaptan, Liver Cirrhosis, Hypertension, Portal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regimen 1 Conivaptan 12.5 mg
Arm Type
Experimental
Arm Description
Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
Arm Title
Regimen 2 Conivaptan 25 mg
Arm Type
Experimental
Arm Description
Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
Arm Title
Regimen 3 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo continuous intravenous infusion over 6.5 hours
Intervention Type
Drug
Intervention Name(s)
conivaptan
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV
Primary Outcome Measure Information:
Title
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose
Description
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
Title
Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose
Description
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
Title
Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose
Description
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
Title
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
Description
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
Title
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
Description
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 Outcome Measure Information:
Title
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
Description
Baseline serum sodium value is the last measurement prior to dosing.
Change from baseline is calculated as time point minus baseline.
Time Frame
Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Art Wheeler, MD
Organizational Affiliation
Cumberland Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.astellas.us/docs/vaprisol.pdf
Description
(Link to Prescribing Information)
Learn more about this trial
A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
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