A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-OLE).

A vizsgálat adatai

Ki végzi

Kardigan Inc.

Azonosító

EU 2026-526139-20-00

A regiszteradat frissítve

2026. november 6.

Eredeti leírás

To assess the long-term safety and tolerability of danicamtiv in participants with symptomatic genetic and familial Dilated Cardiomyopathy (DCM).A teljes eredeti leírásKevesebb

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-OLE).

To assess the long-term safety and tolerability of danicamtiv in participants with symptomatic genetic and familial Dilated Cardiomyopathy (DCM).

Bevonási feltételek: Is an adult ≥18 years of age at the Screening visit; Participants must have completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study; Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All participants, if sexually active, must use a highly effective birth control methods listed in the protocol from the Screening visit through 3 months after the last dose of Investigational Medicinal Product; Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to local and institutional guidelines before the first study-specific procedure.

Kizáró feltételek: Participated in a clinical trial (excluding DAN-301 study) in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to enrollment, or less than 5 times the respective elimination half-life (whichever is longer); Participant is on prohibited medication at the time of enrollment; Recent (<90 days) acute coronary syndrome or hemodynamically significant epicardial coronary disease or coronary revascularization; Has active liver disease; Has hypersensitivity to danicamtiv or any of the components of the danicamtiv formulation; Recent (<90 days) hospitalization for worsening heart failure (HF) or use of intravenous (IV) diuretic; Hospitalization for sepsis or other systemic infections within 30 days of Screening; Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient’s survival; Severe renal insufficiency; History or evidence of any clinically significant disorder, condition, or disease; Anticipated heart transplantation in the next 6 months; Has planned cardiac resynchronization therapy (CRT) or major surgery in the next 6 months; Serum potassium at levels identified in the protocol; Any persistent (2 or more) out-of-range, clinically significant safety laboratory parameters based on Central Laboratory results at enrollment; Hemoglobin at levels identified in the protocol; Serum creatine kinase at levels identified in the protocol; Has a ventricular assist device or ventricular assist device placement planned in the next 6 months; Thyroid-stimulating hormone at levels identified in the protocol; Has life expectancy less than 6 months; Is pregnant or breastfeeding; Is employed by or is a first-degree relative of someone employed by the Sponsor, the Investigator, or his/her staff or family; Other recent (<90 days) cardiovascular events (e.g., cerebrovascular accident).

EU CTIS 2026-526139-20-00