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

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Liver Cirrhosis

Treatments: Drug: conivaptan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00592475

087-CL-089

2007-001661-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

Regimen 1 Conivaptan 12.5 mg

Experimental group

Description:

Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours

Treatment:

Drug: conivaptan

Regimen 2 Conivaptan 25 mg

Experimental group

Description:

Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours

Treatment:

Drug: conivaptan

Regimen 3 Placebo

Placebo Comparator group

Description:

Placebo continuous intravenous infusion over 6.5 hours

Treatment:

Drug: Placebo