ICON - location Groningen
Groningen, 9728 NZ, Netherlands
Location status: Recruiting
NCT Number: NCT07448623
The study is conducted in participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM), a heart disease that occurs in people with the disease ATTR amyloidosis. The purpose of this study is to see how radioactively labelled coramitug is taken up by the heart after administration through an infusion (Cohort 1), and to understand the extent to which coramitug can be displaced by radioactively labelled coramitug (Cohort 2). In this study it will also be investigated how safe coramitug is and how well it is tolerated when it is used by participants with ATTR-CM. Coramitug is potentially a new medicine for participants with ATTR-CM. Coramitug is a monoclonal antibody that potentially binds to the accumulations of the transthyretin protein and promotes its removal from the heart. It may also prevent the formation of clumps and may help with clearing existing clumps of the abnormal protein. The study will take a maximum of 85 days (for Cohort 1) or 106 days (for Cohort 2) when participating in Period A from the screening until the follow-up visit.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a) Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or Grade 3 cardiac uptake at pyrophosphate/3,3-diphosphono-1,2-propanodicarboxylic acid/hydroxymethylene diphosphonate (PYP/DPD/HMDP) scintigraphy with Single-Photon Emission Computed Tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR iii. Grade 2 or Grade 3 cardiac uptake at PYP/DPD/HMDP scintigraphy with SPECT/CT combined with normal serum free light chain ratio & negative serum & urine immunofixation (Serum Immunofixation [SPIE] and Urine Immunofixation [UPIE]) Note: Bone tracer scintigraphy using 99m technetium (Tc)-labelled pyrophosphate (99mTc-PYP)/99mTc-labelled 3,3-diphosphono-1,2- propanodicarboxylic acid (99mTc-DPD)/99mTc-labeled hydroxymethylene diphosphonate (99m-Tc-HMDP) b. Increased LV wall thickness, as assessed by echocardiography showing LV posterior and septal wall thickness greater than or equal to (≥)13 millimeter (mm) for women and ≥ 14 mm for men (Note: Pre-existing echocardiogram up to 2 years old can be used).
c. Chronic HF with: i. At least 1 documented hospitalisation for HF occurring greater than (>) 3 months but less than (<) 2 years, OR ii. History of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary con-gestion on x-ray or auscultation, or peripheral oedema) requiring ongoing treatment with a loop diuretic.
Exclusion criteria
Coramitug will be administered intravenously
Time frame: Day 1-day 8
Measured as ratio.
Time frame: 0 to 168 hours
Measured as milliliter per minute per centimeter cube (mL/min/cm^3).
Time frame: From baseline to week 52 (day 364), or week 60 (day 420) if there is no uptake expected/observed when both unradiolabelled and radiolabelled compounds are administered together
Measured as percentage (%).
Time frame: 0 to 168 hours
microcurie (μCi)
Time frame: 0 to 168 hours
Measured in hours.
Time frame: 0 to 168 hours
Measured in microcurie *hours (μCi*h).
Time frame: 0 to 168 hours
Measured in hours.
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Measured in nanograms per milliliter (ng/mL).
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Measured in hours.
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Measured in nanograms*hours per milliliter (ng*h/mL).
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Measured in hours.
Time frame: From day 1 to day 8 in cohort 1 or day -1 to day 28 for cohort 2
Measured as count of events.
Time frame: From baseline to week 52 (day 364), or week 64 (day 448) if there is no uptake expected/observed when both unradiolabelled and radiolabelled compounds are administered together
Measured as count of events.
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
An Open-label Study to Evaluate the Biodistribution of 89Zr-coramitug and Investigate the Effects of Coramitug on Depleting TTR Amyloid Deposits in Myocardial Tissues Using PET/CT Imaging in Participants With ATTR-CM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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