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Ensayo clínico

Prospective, Open-label, Non-comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) with Voriconazole in Patients with Allogeneic Stem Cell Transplants

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Prospective, Open-label, Non-comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) with Voriconazole in Patients with Allogeneic Stem Cell Transplants


Resumen

2017-03-15 03:55:16
2004-000365-35
A1501038
Prospective, Open-label, Non-comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) with Voriconazole in Patients with Allogeneic Stem Cell Transplants
A1501038

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

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Vfend
Pfizer Limited Voriconazole
N/A Powder for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

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 2:
Test Vfend
Pfizer Limited Voriconazole
N/A Tablet
Oral use

Detalles del Fármaco (Principio Activo):

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 3:
Test Vfend
Pfizer Limited Voriconazole
N/A Tablet
Oral use

Detalles del Fármaco (Principio Activo):

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
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Trasplante Hematopoyético

Secondary Prophylaxis of Invasive Fungal Infections


To evaluate the efficacy of voriconazole as secondary prophylaxis on the rate of occurrence of proven and probable invasive fungal infection (IFI) in allogenic stem cell transplant patients having acute leukemia or acute transformation of chronic myeloid leukemia with previous proven or probable invasive fungal infection from the Day of Transplant until the 12 month Follow-up

To evaluate the efficacy of voriconazole as secondary prophylaxis on the rate of occurrence of proven and probable invasive fungal infection (IFI) from the Day of Transplant until the 6 months Follow-up.To evaluate the efficacy of voriconazole as secondary prophylaxis on the rate of occurrence of proven and probable invasive fungal infection (IFI) from the Day of Transplant until the End of Prophylaxis.To evaluate time to occurrence of proven/probable recurrent/new IFIs from the day of transplant in SCT.To evaluate number of proven/probable recurrent/new IFIs from the day of transplant in SCT.To evaluate the safety of voriconazole, including overall tolerability (number and type of adverse events)To evaluate the number of adverse event leading to discontinuation of the study drug.To evaluate the proportion of patients fungal-free (no fungal infection, no death) at 6 and 12 months after transplant

Information no disponible en EudraCT


Male and female patients with the diagonosis of acute leukemia or acute transformation of chronic myeloic leukemia and with allogenic stem cell transplantation (myeloablative or non-myeloablative regimen), planned in the next 3 weeks and previous proven or probable IFI in the last 6 months, defined according to the MSG/EORTC diagnostic criteria (Ascioglu et al., CID 2002) at the time of the initial diagnosis of IFI, and with no signs or symptoms of active disease.Signed and dated informed consent will be obtainedFemales of childbearing potential must have a negative serum B-HCG pregnancy test and be practicing an effective form of contraceptionAge >= 18 years

Pregnant or lactating women, or women of childbearing potential notusing an acceptable method of contraceptionSevere disease other than underlying condition, likely to jeopardize theplanned termination of the study (e.g. acute myocardial infarction,unstable angina pectoris)Abnormal baseline findings considered by the investigator to beindicative of conditions that might affect study results (e.g. short bowelsyndrome)Previous history of zygomycosis (eg Mucor, Absidia, Rhizopus)Positive serum galactomannan antigen test (level 1.5)Active, symptomatic, uncontrolled IFI (persistence of clinicalsymptoms related to active fungal disease)Any biological fungal criterion of active fungal disease as defined bythe MSG-EORTC criteria, i.e. persistence of positive microbiologicalblood cultures or Aspergillus antigenemia, at time of randomization(Appendix E)Patients with candiduriaPrevious failure of voriconazole in the treatment of IFIKnown intolerance to azole compoundsConcomitant use of sirolimus, ergot alkaloids, terfenadine, astemizole,cisapride, pimozide, quinidine, carbamazepine, rifampicin,phenobarbital, ritonavir or efavirenz which might interfere with theevaluation of study drugs during the study specific systemic diseasesOther medical conditions, including HIV-positive serology, that wouldinterfere with the evaluation of the therapeutic response or safety of thestudy drugAlcohol and/or any other drug abusePrevious participation in this trialAbnormal laboratory test results, defined as impaired hepatic function,as shown by but not limited to (transaminases, alkaline phosphatases,or bilirubin > 5 x Upper Limit of Normal [ULN])Impaired renal function, as shown by but not limited to estimatedcreatinine clearance (Clcr) < 50 mL/minute (as per Cockroft-Gaultformula (Appendix F)Any other condition which, in the investigator's judgment, mightincrease the risk to the subject or decrease the chance of obtainingsatisfactory data to achieve the objectives of the studyMental condition rendering the subject unable to understand the nature,scope and possible consequences of the study and/or evidence of anuncooperative attitudeUnable and/or unlikely to comprehend and/or follow the protocolParticipation in any other studies involving investigational or marketedproducts, concomitantly or within 30 days prior to entry in the studyAnticipated survival less than 72 hours

The primary efficacy variable is the rate of occurrence of proven or probable invasive fungal infections (IFI) between transplant and the 12 months follow-up, defined according to Ascioglu et al. (CID, 2002) criteria

Fase III
  DISEÑO DEL ENSAYO:

No
No

Si
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:


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

2
1
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


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

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


15

Para estudios internacionales:



75

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha