Phase
Condition
Amyloidosis
Circulation Disorders
Treatment
ALXN2060
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Established diagnosis of ATTR-CM with either wild-type TTR or a variant TTRgenotype.
History of heart failure evidenced by at least 1 prior hospitalization for heartfailure or clinical evidence of heart failure without prior heart failurehospitalization manifested by signs or symptoms of volume overload or elevatedpressures or heart failure symptoms that required or requires ongoing treatment witha diuretic.
New York Heart Association Class I-III symptoms due to ATTR-CM.
On stable doses of cardiovascular medical therapy.
Completed ≥ 150 meters on the 6MWT on 2 tests prior to Day 1.
Left ventricular (LV) wall (interventricular septum or LV posterior wall) thickness ≥ 12 millimeters.
Biomarkers of myocardial wall stress: N-terminal pro-brain-type natriuretic pep (NT-proBNP) level ≥ 300 picograms/milliliter (pg/mL).
Exclusion
Exclusion Criteria:
Acute myocardial infarction, acute coronary syndrome or coronary revascularization,or experienced stroke or transient ischemic attack within 90 days prior toscreening.
Hemodynamic instability at screening.
Likely to undergo heart transplantation within a year of screening.
Current treatment with marketed drug products and other investigational agents forthe treatment of ATTR-CM.
Current treatment with calcium channel blockers with conduction system effects (forexample, verapamil, diltiazem). The use of dihydropyridine calcium channel blockersis allowed.
Confirmed diagnosis of light-chain (AL) amyloidosis.
Biomarkers of myocardial wall stress: NT-ProBNP ≥ 8,500 pg/mL.
Measure of kidney function, estimated glomerular filtration rate by Modification ofDiet in Renal Disease formula < 30 mL/minute/1.73 meters squared.
Study Design
Study Description
Connect with a study center
Clinical Trial Site
Aichi,
JapanSite Not Available
Nagoya University Hospital
Aichi,
JapanSite Not Available
Research Site
Bunkyo-ku, 113-8431
JapanSite Not Available
Clinical Trial Site
Fukuoka,
JapanSite Not Available
Kurume University Hospital
Fukuoka,
JapanSite Not Available
Kyushu University Hospital
Fukuoka,
JapanSite Not Available
Research Site
Fukuoka-shi, 812-8582
JapanSite Not Available
Clinical Trial Site
Hokkaido,
JapanSite Not Available
Sapporo Medical University Hospital
Hokkaido,
JapanSite Not Available
Clinical Trial Site
Kanagawa,
JapanSite Not Available
Kitasato University Hospital
Kanagawa,
JapanSite Not Available
Clinical Trial Site
Kochi,
JapanSite Not Available
Kochi Medical School Hospital
Kochi,
JapanSite Not Available
Clinical Trial Site
Kumamoto,
JapanSite Not Available
Kumamoto University Hospital
Kumamoto,
JapanSite Not Available
Research Site
Kumamoto-shi, 860-8556
JapanSite Not Available
Research Site
Kurume-shi, 830-0011
JapanSite Not Available
Research Site
Matsumoto-shi, 390-8621
JapanSite Not Available
Clinical Trial Site
Nagano,
JapanSite Not Available
Shinshu University Hospital
Nagano,
JapanSite Not Available
Research Site
Nagoya-shi, 466-8560
JapanSite Not Available
Research Site
Nankoku-shi, 783-8505
JapanSite Not Available
Clinical Trial Site
Okayama,
JapanSite Not Available
Okayama University Hospital
Okayama,
JapanSite Not Available
Clinical Trial Site
Osaka,
JapanSite Not Available
National Cerebral and Cardiovascular Center
Osaka,
JapanSite Not Available
Research Site
Sagamihara-shi, 252-0375
JapanSite Not Available
Research Site
Sapporo-shi, 060-8543
JapanSite Not Available
Research Site
Shinjuku-ku, 160-8582
JapanSite Not Available
Research Site
Suita-shi, 564-8565
JapanSite Not Available
Clinical Trial Site
Tokyo,
JapanSite Not Available
Juntendo University Hospital
Tokyo,
JapanSite Not Available
Keio University Hospital
Tokyo,
JapanSite Not Available
The University of Tokyo Hospital
Tokyo,
JapanSite Not Available
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