Phase 2
N=20
A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
Liver Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT00592475 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Sep 2010
Primary outcome: Primary: Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose — 16.58; 18.33; 15.80; 0.33 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- conivaptan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose |
16.58; 18.33; 15.80; 0.33; 0.11; -0.10 | — |
| PRIMARY Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose |
581.0; 1182.2; 649.6; 53.5; -74.1; 73.8 | — |
| PRIMARY Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose |
88.3; 90.3; 84.6; -6.2; 3.6; 2.6 | — |
| 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 |
112.2; 115.0; 112.8; 5.3; 5.2; 12.8 | — |
| 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 |
69.0; 77.3; 72.0; 0.7; -6.0; -2.0 | — |
| 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 |
137.3; 137.1; 131.2; -1.3; -1.1; -0.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00592475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.