About this trial
The purpose of Study ALXN2220-ATTRCM-302 is to evaluate the long-term safety, tolerability and efficacy of ALXN2220 in adult participants with ATTR-CM treated with ALXN2220 in addition to SoC who have completed Study ALXN2220-ATTRCM-301.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* Type of Participant: Participants who have completed the Blinded Treatment Period (including the PC visit) of Study 301.
Sex and Contraceptive/Barrier Requirements: Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement).
Informed Consent: Participant, or legally authorized representative where relevant and allowed by law, is willing and able to comply with all study requirements and to provide signed informed consent.
Disqualifiers
Participants who permanently discontinued study intervention in Study 301
Participants who withdrew full consent during Study 301.
Medical Conditions: Suspected or known intolerance/allergy to proteins or any components of ALXN2220. Has had a heart transplant or permanent CMAD implantation. Has any new or worsening of existing medical or psychological condition or risk factor that in the opinion of the Investigator or Sponsor might jeopardize participant's safety or compliance with the protocol, or pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
Prior/Concurrent/Future Clinical Study Experience: Current or future participation in another investigational clinical study or intake of investigational drug within 30 calendar days or 5 half-lives of the study intervention, whichever is longer, before signing the ICF, except for study intervention used in Study 301.
Trial design
Single group
Treatments tested in this trial
ALXN2220
DrugTo be administered as an IV infusion
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants with TEAEs
To evaluate the long-term safety and tolerability of ALXN2220 in participants with ATTR-CM
Secondary outcomes
Total occurrence of ACM and CV clinical events
To evaluate the long-term efficacy of ALXN2220 on ACM and CV clinical events
Total occurrence of CV clinical events
To evaluate the long-term efficacy of ALXN2220 on CV clinical events
Time to ACM
To evaluate the long-term efficacy of ALXN2220 on ACM
Time to first CV clinical event or ACM
To evaluate the long-term efficacy of ALXN2220 on first CV clinical event or ACM
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: