Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio de Fase III, Aleatorio, Doble Ciego, Controlado con Placebo para Evaluar la Eficacia y Seguridad de la Infusión de Prochymal® (Células Madre Mesenquimales Adultas Humanas, Cultivadas Ex-vivo) para el Tratamiento de la EICH (GVHD) Aguda Refractaria a los Esteroides

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Resumen

2017-03-15 04:01:20
2006-004420-37
280
Estudio de Fase III, Aleatorio, Doble Ciego, Controlado con Placebo para Evaluar la Eficacia y Seguridad de la Infusión de Prochymal® (Células Madre Mesenquimales Adultas Humanas, Cultivadas Ex-vivo) para el Tratamiento de la EICH (GVHD) Aguda Refractaria a los Esteroides
280

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Osiris Therapeutics, Inc. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Prochymal
Intravenous infusion
Intravenous use

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Intravenous infusion

Intravenous use

Información General



Terapia Celular, Trasplante Hematopoyético

The proposed indication for Prochymal™ is for treatment of subjects with steroid-refractory acute graft versus host disease (GVHD).


1) To evaluate the efficacy of Prochymal in subjects experiencing steroid-refractory acute GVHD, Grades II-IV.

2) To gather additional information on the safety of Prochymal in subjects experiencing steroid-refractory acute GVHD, Grades II-IV.

No


• Subjects must be 6 months to 60 years of age, inclusive• Subjects who were diagnosed with acute GVHD before day 100 post transplant• Subjects must have Grade II-IV acute GVHD subsequent to allogeneic HSCT or donor leukocyte infusion that has failed to respond to corticosteroid therapy • Subjects must be able to begin Prochymal™ infusion within 3 days of determination of steroid refractory disease. • Subjects must have adequate renal function as defined by:Calculated Creatinine Clearance of >30mL/min using the Cockroft Gault equation• Subjects who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception.• Subject must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry.• Subject (or legal representative where appropriate) must be capable of providing written informed consent.

• Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject (e.g., infection, heart failure, pulmonary hypertension, etc.).• Subjects may not receive any other investigational agents to treat acute GVHD concurrently during study participation.• Subject has a known allergy to bovine or porcine products.• Subjects who are not expected to survive at least four weeks (eg, due to ongoing, active infections or other comorbidities).

Primary Efficacy EndpointComplete response with >/= 28 days duration

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
Information no disponible en EudraCT

Information no disponible en EudraCT

Centros participantes:


Information no disponible en EudraCT
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

1
8
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


1
1

-1

Sexo:


1
1

Número planeado de pacientes a incluir:


Para estudios internacionales:



240

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado