The trial is taking place at:
H

Hospital Universitario Puerta de Hierro Majadahonda | Departamento de Oncologia Medica

Veeva-enabled site

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM (FOREST-HCM)

C

Cytokinetics

Status and phase

Invitation-only
Phase 2

Conditions

Symptomatic Hypertrophic Cardiomyopathy (HCM)

Treatments

Drug: CK-3773274 (5 - 20 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04848506
CY 6022
2020-003571-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

Enrollment

600 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Completion of a Cytokinetics trial investigating CK-3773274 * 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 CK-3773274 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) since the completion of a prior trial of CK-3773274. * Had a confirmed LVEF \<40% with an associated dose interruption during participation in a prior study with CK-3773274 * History of appropriate ICD shock within 30 days prior to screening

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 1 patient group

CK-3773274 up to 20 mg
Experimental group
Description:
Patients in this arm take daily dose of CK-3773274. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.
Treatment:
Drug: CK-3773274 (5 - 20 mg)

Trial contacts and locations

68

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Data sourced from clinicaltrials.gov

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