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Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial – Follow up Long Term Extension (IMPAHCT-FUL)

Overview

Información sobre este estudio

The purpose of this study is to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures (e.g., 6MWD, NT-proBNP, cardiac echo) will also be assessed.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: 

  • Subjects who have consented to participate.
  • Subjects who have successfully completed the placebo-controlled 24-week study AV-101- 002 without a treatment-limiting toxicity resulting in discontinuation of study drug.
  • Female subjects of childbearing potential who have agreed to continue to use a highly effective form of contraception during the LTE and for at least 30 days after completing or discontinuing study treatment (highly effective forms of contraception are described in Section 7.9).

Exclusion Criteria: 

  • Subjects for whom the investigator believes that it would not be in the best interest of the subject to be included in the LTE; e.g., for clinical or social reasons.
  • Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.
  • Clinically relevant history or current psychological abnormality (including alcohol abuse), psychiatric or neurological illness or autonomic neuropathy, which in the opinion of the Investigator could jeopardize or would compromise the subject’s ability to participate in the trial.
  • Recent major surgical intervention which in the opinion of the Investigator would compromise the subject’s ability to participate in the trial.
  • Pregnant or breast-feeding females.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/22/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Charles Burger, M.D.

Abierto para la inscripción

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20540774

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