Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556810
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
IC14 for Treatment of Acute Decompensated Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1b Pilot Study to Evaluate Atibuclimab IC14 for Treatment of Acute Decompensated Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 The main questions it aims to answer are
Is the drug IC14 safe in patients with ADHF What are the IC14 drug levels in the bloodstream after treatment with IC14 What is the impact of IC14 treatment on markers of disease in the bloodstream What is the impact of IC14 treatment on measures of heart failure There is no placebo arm in this study
Participants will
Take drug IC14 once via an intravenous infusion After the infusion be visited in the hospital or visit the clinic 5 times for checkups and tests Answer questions about their medical status via a phone call 3 months after the infusion
Is the drug IC14 safe in patients with ADHF What are the IC14 drug levels in the bloodstream after treatment with IC14 What is the impact of IC14 treatment on markers of disease in the bloodstream What is the impact of IC14 treatment on measures of heart failure There is no placebo arm in this study
Participants will
Take drug IC14 once via an intravenous infusion After the infusion be visited in the hospital or visit the clinic 5 times for checkups and tests Answer questions about their medical status via a phone call 3 months after the infusion
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 determine safety of intravenous IC14 in patients acute decompensated heart failure Exploratory biomarkers clinical outcomes and pharmacokineticpharmacodynamic measurements will be used to design further study of clinical efficacy of IC14 in the treatment of ADHF
To characterize safety of IC14 administered via IV infusion the following assessments are to be performed treatment-emergent adverse events AEs safety laboratory studies serious adverse events SAEs and presence of anti-drug antibodies
To evaluate the effect of IC14 biomarkers including high-sensitivity C-reactive protein hsCRP B-type natriuretic peptide BNP urine sodium and estimated glomerular filtration rate eGFR are measured at baseline and repeatedly after IC14 treatment CRP is an established prognostic marker in heart failure that reflects systemic interleukin-6 as well as interleukin-1 activities Measuring CRP area-under-the-curve allows for integrating measurements across multiple time points to quantify the acute inflammatory response more accurately
Preliminary clinical efficacy will be measured by evaluating heart failure and cardiac performance outcomes at Day 10 including Dyspnea Visual Analogue Scale Congestion Score Doppler echocardiogram non-invasive hemodynamics bioimpedance analysis and cardiopulmonary exercise test
Pharmacokinetics will determine the serum concentration of IC14 over time Pharmacokinetic measurements will be correlated with pharmacodynamic markers of IC14 biologic effect including monocyte CD14 receptor occupancy
The primary objective of this study is to determine safety of intravenous IC14 in patients acute decompensated heart failure Exploratory biomarkers clinical outcomes and pharmacokineticpharmacodynamic measurements will be used to design further study of clinical efficacy of IC14 in the treatment of ADHF
To characterize safety of IC14 administered via IV infusion the following assessments are to be performed treatment-emergent adverse events AEs safety laboratory studies serious adverse events SAEs and presence of anti-drug antibodies
To evaluate the effect of IC14 biomarkers including high-sensitivity C-reactive protein hsCRP B-type natriuretic peptide BNP urine sodium and estimated glomerular filtration rate eGFR are measured at baseline and repeatedly after IC14 treatment CRP is an established prognostic marker in heart failure that reflects systemic interleukin-6 as well as interleukin-1 activities Measuring CRP area-under-the-curve allows for integrating measurements across multiple time points to quantify the acute inflammatory response more accurately
Preliminary clinical efficacy will be measured by evaluating heart failure and cardiac performance outcomes at Day 10 including Dyspnea Visual Analogue Scale Congestion Score Doppler echocardiogram non-invasive hemodynamics bioimpedance analysis and cardiopulmonary exercise test
Pharmacokinetics will determine the serum concentration of IC14 over time Pharmacokinetic measurements will be correlated with pharmacodynamic markers of IC14 biologic effect including monocyte CD14 receptor occupancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None