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

NCT00592475 | Completed Phase 2 Results

• 2 other identifiers: 087-CL-0892007-001661-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cirrhosis

Keywords

conivaptan; Liver Cirrhosis; Hypertension, Portal

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 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.

  Baseline and 0.5, 1, and 1.5 hours post dose

• Change From Baseline in Hepatic Blood Flow (HBF) at 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.

  Baseline and 0.5, 1, and 1.5 hours post dose

• Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 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.

  Baseline and 0.5, 1, and 1.5 hours post dose

• 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

  Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.

  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 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

  Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.

  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

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

  Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose

Study Arms (3)

Regimen 1 Conivaptan 12.5 mg

EXPERIMENTAL

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

Drug: conivaptan

Regimen 2 Conivaptan 25 mg

EXPERIMENTAL

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

Drug: conivaptan

Regimen 3 Placebo

PLACEBO COMPARATOR

Placebo continuous intravenous infusion over 6.5 hours

Drug: Placebo

Interventions

conivaptan DRUG

IV

Regimen 1 Conivaptan 12.5 mg; Regimen 2 Conivaptan 25 mg

Placebo DRUG

IV

Regimen 3 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Barcelona, Spain

Location

Related Links

• (Link to Prescribing Information)

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Interventions

conivaptan

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Results Point of Contact

• Title: Senior Medical Director, Medical Affairs
• Organization: Astellas Pharma Global Development

clinicaltrials@us.astellas.com

Study Officials

• Art Wheeler, MD

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 14, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 15, 2014
• Results First Posted: September 28, 2010

Record last verified: 2014-04

Locations

ES (1)