Hemotrial Un proyecto de SEHH

Ensayo clínico

Prospective, Open-label, Comparative, Multicenter Study of Voriconazole Compared to Itraconazole for the Primary Prophylaxis of Invasive Fungal Infections (IFI) in Subjects with Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

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Resumen

2017-03-15 03:57:36
2005-002800-40
A1501073
Prospective, Open-label, Comparative, Multicenter Study of Voriconazole Compared to Itraconazole for the Primary Prophylaxis of Invasive Fungal Infections (IFI) in Subjects with Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
A1501073

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Laboratorios Pfizer S.A Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test VFEND
Pfizer Limited VFEND
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

(2R, 3S)-2-(2,4

Concentración del fármaco:

mg milligram(s) equal

50

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test VFEND
Pfizer Limited VFEND
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

(2R, 3S)-2-(2,4

Concentración del fármaco:

mg/g milligram( equal

200

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Test VFEND
Pfizer Limited VFEND
Powder and solvent for oral suspension
Oral use

Detalles del Fármaco (Principio Activo):

(2R, 3S)-2-(2,4

Concentración del fármaco:

mg/ml milligram equal

40

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 4:
Test VFEND
Pfizer Limited VFEND
Solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

(2R, 3S)-2-(2,4

Concentración del fármaco:

mg milligram(s) equal

200

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 5:
Test Sporanox™ Liquid
Janssen- Cilag Ltd. Sporanox™ Liquid
Oral solution
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

10

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 6:
Test Sporanox™ Capsules
Janssen-Cilag Ltd. Sporanox™ Capsules
Capsule*
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/g milligram( equal

100

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 7:
Test Sporanox™ I.V.
Janssen-Cilag Ltd. Sporanox™ I.V
Solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

10

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Terapia Celular, Trasplante Hematopoyético

Prophylaxis against invasive fungal infection following allogeneic hematopoietic stem cell transplantation.


The primary objective is to compare the “Success” of antifungal prophylaxis with voriconazole versus itraconazole at 180 days post transplant. Success will be measured using a composite endpoint of: survival to Day 180 with no breakthrough invasive fungal infection and no discontinuation of study drug for > 14 days during the 100-day prophylaxis.

· Success of antifungal prophylaxis (as defined above), but at 100 days post transplant,and comparisons of:· Time to breakthrough invasive fungal infection.· Rates of occurrence of breakthrough invasive fungal infection.· Survival to 180 days post-transplant.· Safety and tolerability of the two study treatments.· Time to discontinuation of study treatment.· Durations of study drug treatment (solid or liquid oral formulations and IV formulation) and rates of empirical therapy.· Use of other systemic antifungal agents as empirical or therapeutic treatment.· Reasons for discontinuation of study treatment.· Survival 1 year after transplant, which will be reported separately.· Subject assessed tolerability of therapy.· Use of healthcare resources.

Information no disponible en EudraCT


Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:· Males or females ? 12 years of age.· Subjects who will be receiving allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failure of therapy for lymphoma or transformation of chronic myeloid leukemia· Signed and dated informed consent will be obtained from each subject in accordance with the local regulatory and legal requirements· Females of childbearing potential must have a negative serum b-HCG pregnancy test and use an approved method of contraception throughout the study

Subjects presenting with any of the following must not be included in the trial:· Probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the “consensus criteria” (Ascioglu et al 2002 ).· Any previous history of zygomycosis (e.g. Mucor, Absidia, Rhizopus).· Use of any systemically active antifungal agent within the 7 days prior to study entry.· Allergy to study drugs or any excipients.· Abnormal laboratory test results, defined as impaired hepatic function, as shown by transaminases or alkaline phosphatase, > 5 x Upper Limit of Normal [ULN], bilirubin >2.5mg/dL.· Severe disease other than underlying condition, likely to jeopardize the planned termination of the study (e.g. acute myocardial infarction, unstable angina pectoris, potentially pro-arrhythmic conditions such as cardiac impairment due to previous cardiotoxic chemotherapy, previous torsade de pointes, prolongation of the QT interval > 450 msec for men or > 470 msec for women).· Concomitant use of sirolimus, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, carbamazepine, rifampicin, phenobarbital, ritonavir or efavirenz which might interfere with the evaluation of study drugs during the study.· Alcohol and/or any other drug abuse.· Previous participation in this trial.· Unable and/or unlikely to comprehend and/or follow the protocol.· Participation in any other studies involving investigational products, concomitantly or within 30 days prior to entry in the study.· Anticipated survival less than one month.

Success at Day 180. This is a multi-component endpoint where all of the following must be met:· Survival until Day 180.· No breakthrough invasive fungal infection.· No discontinuation of study drug for a total of >14 out of 100 days of prophylaxis for any reason.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

1
6
  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:


100

Para estudios internacionales:



500

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha