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.

First Received: January 2, 2008 Last Updated: November 26, 2008 History of Changes

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00592475

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 II

MedlinePlus related topics: Cirrhosis

Drug Information available for: YM 087 Conivaptan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Hemodynamic parameters including hepatic venous pressure gradient (HVPG), hepatic blood flow (HBF), mean arterial pressure (MAP), Heartrate, Blood pressure, Serum sodium and safety (physical exam, ECG, lab measurements, urinalysis and adverse events) [ Time Frame: Baseline to 8 days ] [ Designated as safety issue: No ]

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
1: Experimental Conivaptan IV loading dose followed by conivaptan continuous infusion - regimen 1	Drug: conivaptan IV
2: Experimental Conivaptan IV loading dose followed by conivaptan continuous infusion - regimen 2	Drug: conivaptan IV
3: Placebo Comparator	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

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

Locations

Spain

Barcelona, Spain

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registries )
Study ID Numbers:	087-CL-089, EudraCT No: 2007-001661-15
Study First Received:	January 2, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00592475 History of Changes
Health Authority:	United States: Food and Drug Administration; Spain: Spanish Agency of Medicines

Keywords provided by Astellas Pharma Inc:

conivaptan
Liver Cirrhosis
Hypertension, Portal

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Fibrosis
Portal Hypertension

Hypertension, Portal
Liver Cirrhosis
Hypertension

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Pathologic Processes
Fibrosis
Liver Cirrhosis

ClinicalTrials.gov processed this record on May 07, 2009