Informations générales (source: ClinicalTrials.gov)
A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
Interventional
Phase 2/Phase 3
Cytokinetics (Voir sur ClinicalTrials)
mai 2021
mars 2028
02 décembre 2025
The purpose of this study is to collect long-term safety and tolerability data for
aficamten.
Etablissements
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Tous
- Completion of a Cytokinetics trial investigating aficamten
- LVEF ≥ 55% at the Screening Visit
Exclusion Criteria:
- Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b)
has not received approval for participation from the Medical Monitor.
- Has participated in another investigational device or drug study or received an
investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is
longer) prior to screening. Other investigational procedures while participating in
this study are not permitted.
- Since completion of a previous trial of aficamten has:
- Developed new-onset paroxysmal or permanent atrial fibrillation requiring
rhythm restoring treatment (eg, direct-current cardioversion, ablation
procedure, or antiarrhythmic therapy) < 30 days prior to screening. Patient may
re-screen for CY 6022 after 30 days if heart rate (HR) < 100 bpm and/or rhythm
is stable > 30 days
- Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol
ablation)
- Had a confirmed LVEF < 40% with an associated dose interruption during participation
in a prior study with aficamten
- History of implantable ICD placement within 30 days prior to screening.