Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio doble-ciego, randomizado, estratificado, multicéntrico que evalua la dosis convencional y alta de oseltamivir en el tratamiento de pacientes con gripe inmunocomprometidos.

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Resumen

2017-03-15 03:59:44
2006-002468-24
NV20234
Estudio doble-ciego, randomizado, estratificado, multicéntrico que evalua la dosis convencional y alta de oseltamivir en el tratamiento de pacientes con gripe inmunocomprometidos.
NV20234

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
F.Hoffmann-La Roche Ltd. Switzerland

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Tamiflu
Roche Registration Limited
Powder for oral suspension
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg/ml milligram equal

12

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test Tamiflu
Roche Registration Limited
Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

75

Contenido del fármaco

Si
No

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
Powder for oral suspension

Oral use
  PLACEBO 2:

Si
Capsule, hard

Oral use

Información General

Síndrome Mielodisplásico

Profilaxis estacional de la gripe en pacientes inmunocomprometidos (receptores de un transplante).

To evaluate prospectively the efficacy of oseltamivir for the treatment of influenza in transplant recipients as measured by the time to resolution of influenza symptoms

To evaluate the effects of conventional and high dose oseltamivir in transplant recipients on:• The clinical course of influenza (fever, symptoms, secondary illnesses as evidenced by otitis media, bronchitis, pneumonia, or sinusitis) • The virologic course of influenza (proportion shedding and viral loads at different time points)• Patient safety and tolerability • The development of resistant influenza virus• To characterize the population pharmacokinetics of oseltamivir (e.g. clearance, volume of distribution) in transplant recipients

No


• Age greater than or equal to 1 year• Rapid diagnostic test positive for influenza in the 24 hours prior to first dose• Immunocompromised subject defined as documented:- SOT (liver, kidney or both) recipient OR- Allogenic HSCT • Receiving ongoing immunosuppression, OR, in the investigator’s opinion, not immune reconstituted• Symptoms suggestive of influenza like illness including, but not limited to fever, cough, or coryza • Less or equal 48 hours between onset of influenza like illness and first dose of study drug • Acceptable renal function defined as:- Most recent creatinine clearance in the 6 months prior to randomization is > 30 ml/min in adults and > 30 ml/min /1.73M2 in children. Creatinine clearance estimated from serum creatinine measured when subject is not receiving any renal replacement therapy OR- For patients who have not had a creatinine clearance assessment in the 6 months prior to randomization, baseline creatinine clearance > 10 ml/min in adults and > 10 ml/min /1.73M2 in children OR- For patients whose most recent creatinine clearance in the 6 months prior to randomization is < 30 ml/min in adults and < 30 ml/min /1.73M2 in children, baseline creatinine clearance > 10 ml/min in adults and > 10 ml/min /1.73M2 in children • Parent/guardian willing and able to comply with study requirements and give consent. (country specific age cut off) • Patient able to comply with study requirements and willing to give assent, as appropriate (country specific age cut off)• For adult patients, willing and able to comprehend and give written informed consent• Patients, in the reproductive age group, must agree to utilize an effective method of contraception throughout the study period and for one reproductive cycle following cessation of study therapy • Females of childbearing potential must have a negative urine pregnancy test prior to start of study medication

• SOT within 6 months of the time of randomization • Solid Organ Transplant other than liver, kidney or liver and kidney• Have in the investigator’s opinion experienced acute rejection in the 4 weeks prior to randomization• HSCT patients with no evidence of engraftment (engraftment is defined as the point at which a patient can maintain a sustained absolute neutrophil count (ANC) of >500/mm3 and sustained platelet count of ?20,000/mm3, lasting ?3 consecutive days without transfusions) • HSCT subjects not discharged from hospital after their initial hospitalization for transplantation• Have evidence of veno-occlusive disease, acute or chronic extensive graft versus host disease at the time of randomization• Have clinical evidence for hepatic decompensation at the time of randomization (clinical icterus, ascites, hepatic encephalopathy, coagulopathy)• Have cirrhosis of the liver at the time of randomization• Currently or in the six months prior to randomization using T cell depleting antibodies (example: antithymocyte globulin, antilymphocyte globulin) for management of transplant • Have other co-morbid conditions that could affect patient survival or graft function including, but not limited to, a post-transplant lymphoproliferative disease (PTLD), autoimmune disease including inflammatory bowel disease and psoriasis, untreated thyroid disease, and significant active infection• Patients currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis or hemofiltration• Have evidence of active or uncontrolled opportunistic infections (bacterial, fungal, or viral - including cytomegalovirus [CMV] or polyoma virus [BKV]) at the time of randomization. Patients with HCV or HBV are not excluded.• Patients with known HIV infection• Patients who are being evaluated or treated for an active malignancy (other than the malignancy for which the SOT or HSCT may have been performed) at the time of randomization • Patients with uncontrolled vascular, neurologic or pulmonary disease. Uncontrolled is defined as disease requiring change of therapy or hospitalization in the 4 weeks preceding randomization. Change of therapy is defined as dose increase or change of medication prior to onset of present influenza like illness.• Patients with severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy• Allergy to the test medication• Patients with hereditary fructose intolerance (for subjects who will be taking the liquid formulation)• Influenza vaccination in the 2 weeks prior to randomization• Antiviral treatment (example: amantadine, rimantadine, zanamivir and ribavirin) for influenza in the 2 weeks prior to randomization• Patients taking probenecid medication• Patients who are pregnant or breast-feeding • Participation in a clinical trial or expanded access trial with an investigational drug in the 4 weeks prior to randomization or concomitantly with this study

The primary endpoint in this study is the time to alleviation of all clinical influenza symptoms (recorded in the diary card).

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
No

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:

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

1
  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:

20

Para estudios internacionales:

165
250

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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En Marcha