AzTrials
AzTrials

Heart Failure, CongestivePhase 1NCT00487799

A Study of Ularitide in the Treatment of Subjects With Acute Decompensated Heart Failure

A Phase 1 study testing Ularitide in people with Heart Failure, Congestive, run by Facet Biotech at 8 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

To determine the maximum tolerated dose (MTD) of ularitide in the treatment of subjects hospitalized with symptomatic acute decompensated heart failure (ADHF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Ularitide
How many people
32 participants
Where
8 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 1
Are there results?
None posted in the registry

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

  • To be considered eligible for inclusion, subjects must meet all of the following criteria:
  • Males and females who are 18 years or older.
  • Unplanned hospitalization for ADHF.
  • Randomization should occur as soon as possible from presentation to emergency department or hospital for ADHF up to 24 hours from admission.
  • Dyspnea at rest as assessed by the subject not more than 1 hour prior to randomization. Subjects must have the ability to interpret and report self-assessed dyspnea.
  • At least 1 of the following 2 criteria:
Show all 14Show fewer
  • Prior medical history of CHF (eg, prior hospitalization for CHF or left ventricular ejection fraction <40%, as determined by transthoracic echocardiography at the time of screening or previously determined and documented in the patient's chart as follows):
  • Within the previous 6 months in subjects with unstable symptoms, or
  • Within the previous 12 months in subjects with stable symptoms.
  • Clinical evidence (at screening) of heart failure, including abnormal jugular venous pressure (JVP) (eg, >8 cm above the clavicle, assessed at 45°angle), rales or crackles more than a third above bases, or 2+ lower extremity edema.
  • On optimal background therapy for ADHF (as determined by the investigator); subjects are required to have received, at a minimum, at least 1 hour of oxygen supplementation and at least one dose of IV furosemide at a minimum dose of 40 mg with the last bolus being delivered >2 hours before study drug administration is initiated (or another diuretic at a comparable dose; eg, 2 mg bumetanide or 20 mg torsemide, with the last bolus being delivered >4 hours before study drug administration is initiated.
  • If subject received IV opiate, the last dose must have been >3 hours before administration of study drug.
  • Women of childbearing potential must have a negative pregnancy test prior to being randomized in the study. Women and men of reproductive potential will agree to utilize effective contraception during the entire treatment period and for 1 month after receiving the last dose of ularitide or placebo.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

Who cannot join

  • Any subject will be ineligible for this study if any one of the following criteria is met:
  • Breathing rate <18 breaths per minute (measured during 60 seconds).
  • A systolic blood pressure (SBP) <110 mmHg or >180 mmHg within an hour before randomization, or SBP <120 mmHg for subjects receiving IV inotropics or vasodilators. A SBP <90 mmHg in two successive measurements within 30 minutes before randomization. (Subjects on baseline IV inotropes or vasodilators must be on a stable dose for ³3 hours prior to randomization.)
  • BNP <400 pg/mL or NT?pro-BNP <1200 pg/mL anytime from initial presentation to hospital to time of randomization.
  • Use of IV contrast material within 48 hours before infusion of study drug.
  • History of central or peripheral neurological ischemic disorder (stroke, etc.).
Show all 30Show fewer
  • Active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy, constrictive pericarditis, severe aortic stenosis, uncorrected primary valvular disease, or significant obstructive valve disease.
  • Acute decompensated heart failure associated with endocrine (eg, thyroid storm), metabolic, or drug-related toxicity.
  • Elevation of serum creatinine?kinase myocardial band (CK?MB) or cardiac troponin (Troponin I) >2 times the upper limit of normal within 6 hours prior to randomization.
  • Active, ongoing myocardial ischemia, hospitalization for acute myocardial infarction, or administration of thrombolytic therapy in the last 30 days prior to randomization, or, any ECG abnormalities in the opinion of the investigator, suggestive of active ischemic changes.
  • Percutaneous coronary intervention, coronary artery bypass graft surgery, other cardiac surgery, or major noncardiac surgery within 90 days prior to randomization.
  • Any cardiogenic shock (SBP <90 mmHg with signs or symptoms of organ hypoperfusion) from initial presentation to randomization.
  • Any significant volume depletion or severe electrolyte imbalance.
  • Renal disorder with a creatinine clearance <30 mL/min, as calculated by the Cockcroft-Gault equation at screening.
  • Use of a phosphodiesterase type 5 (PDE 5) inhibitor such as sildenafil within 72 hours prior to randomization.
  • Planned coronary revascularization procedure (percutaneous coronary intervention or coronary artery bypass grafting) during current hospital admission.
  • Use or anticipated need for invasive or noninvasive mechanical circulatory or ventilatory support.
  • Anemia (hemoglobin <10 mg/dL or a hematocrit <30%).
  • Vasculitis, active infective endocarditis, or suspected infections including pneumonia or sepsis.
  • Body temperature ≥ 38º C.
  • Significant acute or chronic respiratory disorder (eg, severe chronic obstructive pulmonary disease) or primary pulmonary hypertension with baseline dyspnea that may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements.
  • Terminal illness other than CHF with expected survival <180 days.
  • Previous exposure to ularitide.
  • Nesiritide treatment in the last 30 days prior to randomization.
  • Allergy to natriuretic peptides.
  • Participation in a clinical drug trial or investigational device trial within 30 days prior to randomization.
  • Current drug abuse or chronic alcoholism (at the Investigator's determination).
  • Women who are pregnant or breast-feeding. Women of childbearing age will have a urine pregnancy test to determine pregnancy status within 24 hours prior to randomization.
  • Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation, including a history of repeated admission related to non-adherence to prescribed medication.
  • For subjects with concomitant invasive hemodynamic monitoring (ie, pulmonary artery catheter monitoring): Baseline PCWP ≤ 20 mmHg.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • The Atlanta Cardiology Group, PC

    Atlanta, Georgia, 30342

  • Feinberg School of Medicine, Northwestern Univ.

    Chicago, Illinois, 60611

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Kore Cardiovascular Research Institute

    Lexington, Tennessee, 38351

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • UCSD Medical Center

    San Diego, California, 92103

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Cardiovascular Specialists PC dba New York Heart Ctr.

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Ularitide in the Treatment of Subjects With Acute Decompensated Heart Failure

To determine the maximum tolerated dose (MTD) of ularitide in the treatment of subjects hospitalized with symptomatic acute decompensated heart failure (ADHF).

Being tested
Ularitide
Keywords
Acute Decompensated Heart Failure, ADHF, Heart Failure
Medical subject headings
Heart Failure

What participants receive

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

  • UlaritideDrug

What is being measured

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

  1. The MTD of ularitide infused over 48 hours.

Secondary outcomes (5)

  1. Frequency, severity, and relationship of AEs and serious adverse events (SAEs) to study drug through Day 32 (ie, 30 days following the end of study drug infusion).

  2. Physical examinations, vital signs, electrocardiography, and clinical laboratory values through 48 hours.

  3. Decline in renal function defined as a >25% rise or a 0.3 mg/dL increase in serum creatinine from pre-dose at baseline to 48 hours post the end of infusion and through Day 32.

  4. Pharmacokinetic profile including Css, AUC, CL, V, and t½ up to 2 hours post end of infusion.

  5. Incidence of ularitide-specific anti-drug antibodies (ADAb) through Day 32.

Timeline

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

  1. First posted19 Jun 2007 (estimated)

Why it stopped: Facet no longer has ownership of ularitide.

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00487799
Sponsor's protocol ID
Ularitide-1503
Status last verified
Jul 2009
First submitted
15 Jun 2007
Last updated
20 Jul 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ularitide in people with Heart Failure, Congestive, run by Facet Biotech at 8 sites in United States.

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 14 inclusion and 30 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: withdrawn, as of the sponsor's last update on 20 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

The MTD of ularitide infused over 48 hours.. 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 NCT00487799.

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 20 Jul 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in