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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00592475
First received: January 2, 2008
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
Drug: conivaptan
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose [ Time Frame: Baseline and 0.5, 1, and 1.5 hours post dose ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and 0.5, 1, and 1.5 hours post dose ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and 0.5, 1, and 1.5 hours post dose ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose ] [ Designated as safety issue: No ]

    Baseline serum sodium value is the last measurement prior to dosing.

    Change from baseline is calculated as time point minus baseline.



Enrollment: 20
Study Start Date: December 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1 Conivaptan 12.5 mg
Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
Drug: conivaptan
IV
Experimental: Regimen 2 Conivaptan 25 mg
Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
Drug: conivaptan
IV
Placebo Comparator: Regimen 3 Placebo
Placebo continuous intravenous infusion over 6.5 hours
Drug: Placebo
IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592475

Locations
Spain
Barcelona, Spain
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00592475     History of Changes
Other Study ID Numbers: 087-CL-089, 2007-001661-15
Study First Received: January 2, 2008
Results First Received: May 24, 2010
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines

Keywords provided by Cumberland Pharmaceuticals:
conivaptan
Liver Cirrhosis
Hypertension, Portal

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014