Hemotrial Un proyecto de SEHH

Ensayo clínico

A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy

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Resumen

2017-03-15 03:55:11
2004-000174-31
20030105
A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
20030105

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Amgen Inc United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
AMG 531
AMG 531 Powder for solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):
AMG 531

Concentración del fármaco:
mg/ml milligram equal

0.5

Contenido del fármaco

No
Si

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

Information no disponible en EudraCT
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Powder for solution for injection

Subcutaneous use

Información General

Trombopenia

Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)

To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP refractory to splenectomy as measured by the platelet response

1.To evaluate the overall safety of AMG 5312.To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 5313.To evaluate changes in Patient Reported Outcomes (PRO) and Health Resource Utilization (HRU) due to treatment with AMG 531

Information no disponible en EudraCT


1.Diagnosis of ITP according to American Society of Hematology (ASH) guidelines 2.Have had a splenectomy for the treatment for ITP ? 24 weeks prior to study entry3.Subjects > 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis4.The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be: less than or equal to 30 x 109/L for those subjects not receiving any ITP therapy less than or equal to 50 x 109/L for those subjects receiving a constant dose schedule (no adjustment for 4 weeks) of corticosteroids, azathioprine, or danazol5.Subjects must be more than or equal to 18 years of age at the time of obtaining the informed consent6.A serum creatinine concentration less than or equal to2 mg/dl (less than or equal to 176.8 mcmol/L)7.Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range8.Hemoglobin > 11.0 g/dL9.Before any study-specific procedure, the appropriate written informed consent must be obtained

1..Any known history of bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study)2.Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization3.Currently receiving any treatment for ITP except corticosteroids, azathioprine, or danazol administered at a constant dose and schedule4.IV Ig or anti-D Ig within 2 weeks before the screening visit5.Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study6.Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit7.Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study8.Subject is currently enrolled in or has not yet completed at least 4 weeks since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)9.Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or related platelet product10.Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding11.Subject is not using adequate contraceptive precautions12.Known hypersensitivity to any recombinant E coli -derived product13.Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with all study procedures

The primary endpoint is the incidence of platelet response defined as the proportion of subjects achieving a platelet count double the baseline and greater than or equal to 50 x109/L in the absence of rescue medication during the treatment period.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:

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


11
  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:

3

Para estudios internacionales:

10
60

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 EC Finalizado



EC Finalizado