ACTIVE_NOT_RECRUITING

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

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Conditions

Transthyretin Amyloid CardiomyopathyAmyloid DepleterALXN2220All-cause mortality (ACM)Cardiovascular (CV)Transthyretin amyloid (ATTR)Transthyretin (TTR)N-terminal pro b-type natriuretic peptide (NT-proBNP)NT-proBNPAmyloidosisATTR-CM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to access the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the total occurrences of all-cause mortality (ACM) and cardiovascular (CV) clinical events.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Quick Facts

Study Start:2024-01-11
Study Completion:2027-10-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06183931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of ATTR-CM with either wild-type or variant TTR genotype
  2. * End-diastolic interventricular septal wall thickness ≥ 12 mm on echocardiography measured at Screening
  3. * NT-proBNP \> 2000 pg/mL at Screening
  4. * Treatment with a loop diuretic for at least 30 days prior to Screening
  5. * History of heart failure NYHA Class II-IV at Screening
  6. * Life expectancy of ≥ 6 months as per the Investigator's judgment
  7. * Males and females of childbearing ability must use contraception
  1. * Known leptomeningeal amyloidosis
  2. * Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis
  3. * Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
  4. * Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment
  5. * LVEF \< 30% on echocardiography
  6. * Renal failure requiring dialysis or an eGFR \< 20 mL/min/1.73 m2 at Screening
  7. * Polyneuropathy with PND score IV

Contacts and Locations

Study Locations (Sites)

Research Site
Irvine, California, 92614
United States
Research Site
La Jolla, California, 92037
United States
Research Site
Palo Alto, California, 94304
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Washington, District of Columbia, 20010
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Weston, Florida, 33331
United States
Research Site
Atlanta, Georgia, 30309
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Indianapolis, Indiana, 46202
United States
Research Site
Boston, Massachusetts, 02115
United States
Research Site
Boston, Massachusetts, 02118
United States
Research Site
Kansas City, Missouri, 64111
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10032
United States
Research Site
Stony Brook, New York, 11794
United States
Research Site
Chapel Hill, North Carolina, 27599
United States
Research Site
Durham, North Carolina, 27705
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Danville, Pennsylvania, 17822
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Charleston, South Carolina, 29425
United States
Research Site
Greenville, South Carolina, 29605
United States
Research Site
Memphis, Tennessee, 38120
United States
Research Site
Fort Worth, Texas, 76104
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Salt Lake City, Utah, 84132
United States
Research Site
Falls Church, Virginia, 22042
United States
Research Site
Richmond, Virginia, 23298
United States
Research Site
Seattle, Washington, 98195
United States
Research Site
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11
Study Completion Date2027-10-05

Study Record Updates

Study Start Date2024-01-11
Study Completion Date2027-10-05

Terms related to this study

Keywords Provided by Researchers

  • Amyloid Depleter
  • ALXN2220
  • All-cause mortality (ACM)
  • Cardiovascular (CV)
  • Transthyretin Amyloid Cardiomyopathy
  • Transthyretin amyloid (ATTR)
  • Transthyretin (TTR)
  • N-terminal pro b-type natriuretic peptide (NT-proBNP)
  • NT-proBNP
  • Amyloidosis
  • ATTR-CM

Additional Relevant MeSH Terms

  • Transthyretin Amyloid Cardiomyopathy