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Trial · NCT06678074

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of treatment-emergent adverse events (safety and tolerability)Day 1-29Treatment-emergent adverse events
SecondaryCCR2+ cell myocardial infiltration (optional)48 hours and Day 15Characterization of CCR2+ cell myocardial infiltration mean standard uptake value (SUVmean) and change from 48 hours measured by myocardial PET/CT imaging at Day 15
SecondaryBiomarker C-Reactive ProteinDay 4, 15, 29Change from baseline
SecondaryBiomarker White Blood Cell CountDay 4, 15, and 29Change from baseline
SecondaryBiomarker FibrinogenDay 4, 15, 29Change from baseline
SecondaryBiomarker Interleukin 6Day 4, 15, and 29Change from baseline
SecondaryBiomarker Interleukin-1Day 4, 15, and 29change from baseline
SecondaryBiomarker Troponin IDay 4, 15, and 29change from baseline
SecondarySingle-cell RNASeqDay 4, 15, and 29change from baseline
SecondaryCardiac death or readmission for heart failureDay 1-90
* Cardiac death defined as death due to acute MI, sudden cardiac death, HF, stroke, cardiovascular procedure, cardiovascular hemorrhage, or other cardiovascular cause. * Heart failure readmission, defined as an event in which the patient is admitted to the hospital with a primary diagnosis of HF, the length of stay is at least 24 hours (or extends over a calendar date), the patient exhibits new or worsening symptoms of HF on presentation, has objective evidence of new or worsening HF, and receives initiation or intensification of treatment specifically for HF.
SecondaryLeft Ventricular Ejection FractionDay 1, Day 90Change from baseline, measured by echocardiography
SecondaryN-terminal pro B-type natriuretic peptideDay 90blood test measurement of heart failure
SecondaryNew York Heart Association ClassDay 90Measurement of cardiac status
SecondaryKansas City Cardiomyopathy QuestionnaireDay 90Patient-reported outcome measure of health status and function
OtherPharmacokinetic profile of serum IC14 level, including serum half life and maximum serum concentrationbaseline, 15 minutes, 6 hours, Day 4, Day 15, Day 22, Day 29Serum IC14 levels
OtherPharmacodynamicsDay 22, Day 29Percent monocyte CD14 receptor occupancy
OtherImmunogenicitybaseline, Day 29, Day 90Anti-drug antibodies

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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