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Completed

NCT Number: NCT00592475

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

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conivaptan

Drug

IV

Placebo

Drug

IV

Primary outcomes

  1. 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

    Change from baseline is calculated as time point minus baseline.

    Baseline procedures were performed prior to study drug administration.

  2. 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

    Change from baseline is calculated as time point minus baseline.

    Baseline procedures were performed prior to study drug administration.

  3. 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

    Change from baseline is calculated as time point minus baseline.

    Baseline procedures were performed prior to study drug administration.

  4. 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

    Change from baseline is calculated as time point minus baseline.

    Baseline procedures were performed prior to study drug administration.

  5. 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

    Change from baseline is calculated as time point minus baseline.

    Baseline procedures were performed prior to study drug administration.

Secondary outcomes

  1. 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

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

    Change from baseline is calculated as time point minus baseline.

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 14, 2008
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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