Status:
ACTIVE_NOT_RECRUITING
IC14 for Treatment of Acute Decompensated Heart Failure
Lead Sponsor:
Implicit Bioscience
Collaborating Sponsors:
University of Virginia
Virginia Commonwealth University
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to learn if drug atibuclimab (IC14) works to treat adults hospitalized with acute decompensated heart failure (ADHF). It will also learn about the safety of IC14. Th...
Detailed Description
The proposed investigation is a pilot study to evaluate the safety and exploratory efficacy of IC14 administered via IV infusion in patients with ADHF. The primary objective of this study is to deter...
Eligibility Criteria
Inclusion
- Patients may be included in the study only if they meet all of the following criteria:
- Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:
- dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and
- evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met):
- Pulmonary congestion/edema a physical exam OR chest x-ray;
- plasma BNP levels ≥200 pg/ml or N-terminal-proBNP ≥600 pg/ml; or
- invasive measurement of left ventricular end-diastolic pressure (LVEDP) \>18 mmHg or of pulmonary artery occluding pressure (wedge pressure) \>16 mmHg.
- The patient has a prior documentation of impaired left ventricular systolic function (left ventricular ejection fraction \<40%) at most recent assessment by any imaging modality (within 12 months).
- The patient is symptomatic for moderate to severe dyspnea at time of enrollment as indicated by a score on the visual analog scale for dyspnea of 40 or more (in a scale of 1 to 100, where 0 is no shortness of breath and 100 is extremely short of breath) in the prior 12 hours.
- The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics.
- The patient is of age ≥21 years old, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms).
- The patient has screening plasma C-reactive protein levels \>3 mg/L (0.3 mg/dL).
- Males and females of childbearing potential must use effective contraception.
Exclusion
- The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
- Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes; uncontrolled hypertension or orthostatic hypotension; tachy- or brady-arrhythmias; acute or chronic pulmonary disease; or neuromuscular disorders affecting respiration.
- Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries.
- Previous or planned implantation of left ventricular assist devices or heart transplant.
- Current or planned use of intravenous inotropes.
- Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs or colchicine).
- Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
- Active infection (of any type), including chronic/recurrent infectious disease (including hepatitis B virus, hepatitis C virus, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA.
- Active malignancy - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer.
- Any comorbidity limiting survival or ability to complete the study, including end-stage heart failure.
- Stage V kidney disease or on renal-replacement therapy or renal transplant recipient.
- Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African-American patients).
- Pregnancy.
- Hypersensitivity to IC14 or previous adverse reaction to antibody-based treatments.
Key Trial Info
Start Date :
October 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06556810
Start Date
October 17 2024
End Date
January 31 2026
Last Update
September 5 2025
Active Locations (2)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908
2
Virginia Commonwealth University
Richmond, Virginia, United States, 23298