Liver CirrhosisPhase 2NCT00592475

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

A Phase 2 study testing conivaptan in people with Liver Cirrhosis, run by Cumberland Pharmaceuticals at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Cirrhosis
What is being tested?: conivaptan
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteSpain
Study dates: Dec 2007to Nov 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Spain1 site

Study site
Barcelona

Other trials in Spain

About this 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

Conditions: Liver Cirrhosis
Being tested: conivaptan, Placebo
Keywords: conivaptan, Liver Cirrhosis, Hypertension, Portal
Medical subject headings: Liver Cirrhosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

conivaptanDrug
IV
PlaceboDrug
IV

Study groups in NCT00592475
Study group	Role	What they receive
Regimen 1 Conivaptan 12.5 mg	Experimental	Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours Receives: Drug: conivaptan
Regimen 2 Conivaptan 25 mg	Experimental	Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours Receives: Drug: conivaptan
Regimen 3 Placebo	Placebo comparator	Placebo continuous intravenous infusion over 6.5 hours Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 serum sodium value is the last measurement prior to dosing.
Change from baseline is calculated as time point minus baseline.
Measured: Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Nov 2008

First posted14 Jan 2008 (estimated)
Study startDec 2007
Primary completionNov 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver CirrhosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00592475
Sponsor's protocol ID: 087-CL-089
Other IDs: 2007-001661-15
Status last verified: Apr 2014
First submitted: 2 Jan 2008
Last updated: 15 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00592475
Acronym / sponsor ID: 087-CL-089
Conditions: Liver Cirrhosis
Keywords: conivaptan, Liver Cirrhosis, Hypertension, Portal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 14 Jan 2008 (estimated)
Results: Posted 28 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Regimen 1 Conivaptan 12.5 mg	Experimental	Drug: conivaptanConivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
Regimen 2 Conivaptan 25 mg	Experimental	Drug: conivaptanConivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
Regimen 3 Placebo	Placebo comparator	Drug: PlaceboPlacebo continuous intravenous infusion over 6.5 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
conivaptanIV	Drug	Regimen 1 Conivaptan 12.5 mg, Regimen 2 Conivaptan 25 mg
PlaceboIV	Drug	Regimen 3 Placebo

Primary outcome

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.
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.
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.
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.
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 28 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regimen 1 Conivaptan 12.5 mg	6	6
Regimen 2 Conivaptan 25 mg	9	9
Regimen 3 Placebo	5	5

Primary outcome: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Regimen 1 Conivaptan 12.5 mg n = 6	Regimen 2 Conivaptan 25 mg n = 9	Regimen 3 Placebo n = 5
Baseline	16.58 (4.375)	18.33 (4.750)	15.80 (6.601)
Change at 0.5 Hours	0.33 (1.080)	0.11 (1.318)	-0.10 (0.224)
Change at 1 Hour	0.50 (1.844)	0.56 (1.357)	-0.60 (0.418)
Change at 1.5 Hours	0.83 (2.113)	0.83 (1.732)	-0.10 (1.294)

Population analysed: Participants Analyzed represents Full Analysis Set (FAS): All randomized patients who had at least 1 dose of study drug \& who had hepatic venous pressure gradient data at baseline. The number of participants per arm is consistent for all categories of the data table.

Primary outcome: 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. Mean (Standard Deviation). Unit: mL/min

Measure	Regimen 1 Conivaptan 12.5 mg n = 6	Regimen 2 Conivaptan 25 mg n = 9	Regimen 3 Placebo n = 5
Baseline (N= 4; 9; 5)	581.0 (77.49)	1182.2 (530.56)	649.6 (300.44)
Change at 0.5 Hours (N= 4; 9; 5)	53.5 (161.30)	-74.1 (558.58)	73.8 (196.75)
Change at 1 Hour (N= 4; 9; 4)	1.3 (160.23)	-70.0 (318.35)	-67.5 (270.27)
Change at 1.5 Hours (N= 4; 9; 5)	15.8 (60.26)	-96.0 (390.96)	40.8 (154.33)

Population analysed: Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug \& who had hepatic venous pressure gradient data at baseline. (Note: 2 patients were not included in the analysis due to protocol deviations.) The number of participants included in the calculation for each timepoint is noted in the category title.

Primary outcome: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Regimen 1 Conivaptan 12.5 mg n = 6	Regimen 2 Conivaptan 25 mg n = 9	Regimen 3 Placebo n = 5
Baseline (N= 6; 9; 5)	88.3 (11.89)	90.3 (7.79)	84.6 (13.63)
Change at 0.5 Hours (N= 6; 8; 5)	-6.2 (9.66)	3.6 (9.97)	2.6 (4.72)
Change at 1.0 Hour (N= 6; 9; 5)	-4.2 (9.28)	5.7 (13.18)	7.8 (10.92)
Change at 1.5 Hours (N= 6; 9; 5)	0 (7.77)	8.8 (11.39)	3.4 (6.31)

Population analysed: Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug \& who had hepatic venous pressure gradient data at baseline. The number of participants included in the calculation for each timepoint is noted in the category title.

Primary outcome: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Regimen 1 Conivaptan 12.5 mg n = 6	Regimen 2 Conivaptan 25 mg n = 9	Regimen 3 Placebo n = 5
Systolic Blood Pressure- Baseline	112.2 (13.73)	115.0 (14.42)	112.8 (12.03)
Systolic Blood Pressure- Change at 0.5 Hours	5.3 (13.29)	5.2 (9.86)	12.8 (17.54)
Systolic Blood Pressure- Change at 1 Hour	5.5 (17.62)	13.9 (14.12)	6.8 (21.39)
Systolic Blood Pressure- Change at 1.5 Hours	7.8 (20.90)	7.2 (12.59)	1.2 (16.27)
Systolic Blood Pressure- Change at 2.5 Hours	-2.5 (9.65)	-3.8 (8.15)	-2.6 (18.69)
Systolic Blood Pressure- Change at 3.5 Hours	-6.0 (8.94)	-6.3 (14.83)	-11.4 (10.36)
Systolic Blood Pressure- Change at 4.5 Hours	-6.2 (12.91)	-17.1 (11.54)	-8.2 (2.95)
Systolic Blood Pressure- Change at 5.5 Hours	-6.3 (7.20)	-8.7 (14.94)	-7.6 (2.30)

Population analysed: Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication. The number of participants per arm is consistent for all categories of the data table.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen 1 Conivaptan 12.5 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Regimen 2 Conivaptan 25 mg	2 of 9 (22.2%)	6 of 9 (66.7%)	Not reported
Regimen 3 Placebo	0 of 5 (0%)	0 of 5 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
(Link to Prescribing Information)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Art Wheeler, MD study director

Cumberland Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing conivaptan in people with Liver Cirrhosis, run by Cumberland Pharmaceuticals at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00592475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.