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First-in-Human, Open-Label, Safety, Tolerability, Dose Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-401, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Plakophilin-2 (PKP2) Transgene, in Adults with PKP2 Mutation-associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Rochester, Minn.
The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-401 in adult patients with symptomatic PKP2 mutation-associated ARVC. The trial will consist of 2 escalating dose cohorts. All patients will receive active drug.
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First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-201, a Recombinant Adenoassociated Virus Serotype 9 (AAV9) Containing Myosin Binding Protein C Transgene, in Adults With MYBPC3 Mutation-Associated Hypertrophic Cardiomyopathy (HCM) (MyPEAK-1)
Rochester, Minn.
This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic MYBPC3 mutation-associated nonobstructive hypertrophic cardiomyopathy (nHCM).
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Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV) in Patients with Plakophilin 2 (PKP2)-associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Rochester, Minn.
The purpose of this multicenter, seroprevalence study to assess pre-existing antibodies to Adenovirus-associated Virus Vector (AAV) in a population of patients with Plakophilin 2 (PKP2)-associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), who may be eligible for subsequent gene therapy trials. Biological samples and clinical data will be collected over a period of up to 5 years from the date of enrollment. No investigational product will be administered.
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International CRDS Registry
Rochester, Minn.
The purpose of this research study is to establish a large registry of individuals diagnosed with CRDS, along with individuals that have genetic changes that could potentially place them at risk for a CRDS-like condition, from around the world.
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