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Monoclonal Antibodies
IC14 for Heart Failure
Phase 1 & 2
Recruiting
Led By Antonio Abbate, MD
Research Sponsored by Implicit Bioscience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a primary diagnosis for hospitalization of decompensated heart failure with specific criteria including dyspnea, respiratory distress, elevated cardiac filling pressure, and impaired left ventricular systolic function
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if the drug atibuclimab (IC14) can help adults with acute decompensated heart failure (ADHF). It will check the safety of IC14 and
Who is the study for?
This trial is for adults hospitalized with acute decompensated heart failure (ADHF). Participants must be currently admitted for ADHF to qualify. Specific inclusion and exclusion criteria details are not provided, but typically these would outline the health status and other conditions that either qualify or disqualify a person from participating.
What is being tested?
The trial is testing atibuclimab (IC14), administered once via IV infusion, to treat ADHF. It aims to assess the safety of IC14, its levels in the bloodstream post-treatment, its effect on disease markers in blood, and how it impacts heart failure measures. There's no placebo comparison; all participants receive IC14.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with new treatments like IC14 could include reactions at the infusion site, allergic responses, changes in blood pressure or heart rate, fatigue, nausea or other gastrointestinal symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was hospitalized for worsening heart failure, experiencing shortness of breath, and have a weak heart pump.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety of IC14 treatment
Secondary study objectives
B-type natriuretic peptide, biomarker of heart failure
Bioimpedance analysis
C-reactive protein, biomarker of inflammation
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: IC14 (atibuclimab)Experimental Treatment1 Intervention
20 mg/kg intravenously once at baseline
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityOTHER
719 Previous Clinical Trials
22,895,826 Total Patients Enrolled
25 Trials studying Heart Failure
4,792 Patients Enrolled for Heart Failure
University of VirginiaOTHER
785 Previous Clinical Trials
1,316,436 Total Patients Enrolled
12 Trials studying Heart Failure
1,565 Patients Enrolled for Heart Failure
Implicit BioscienceLead Sponsor
11 Previous Clinical Trials
130 Total Patients Enrolled
Antonio Abbate, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Heart Failure
30 Patients Enrolled for Heart Failure