Hemotrial Un proyecto de SEHH

Ensayo clínico

An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects with immune (Idiopathic) Thrombocytopenia Purpura (ITP).------------------------------------------------Estudio Abierto para Evaluar la Seguridad y Eficacia del Tratamiento a Largo Plazo con Romiplostim en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI).

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Resumen

2017-01-29 10:19:11
2009-016203-32
20090340
https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-016203-32/ES/
An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects with immune (Idiopathic) Thrombocytopenia Purpura (ITP).------------------------------------------------Estudio Abierto para Evaluar la Seguridad y Eficacia del Tratamiento a Largo Plazo con Romiplostim en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI).
20090340

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
NPLATE
Powder for solution for injection
Subcutaneous 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:

No hay placebos asignados al ensayo

Información General

Trombopenia

Thrombocytopenia in pediatric subjects with ITP---------Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)

The primary objective of this study is to evaluate the safety of romiplostim as a long-term treatment in pediatric thrombocytopenic subjects with immune (idiopathic) thrombocytopenic purpura (ITP).

This study will also evaluate the long-term platelet response to romiplostim as well as the possible reductions in the dose of concurrent ITP therapies while receiving romiplostim.

No


Ethical- Subject or subject's legally acceptable representative has provided informed consent.Demographic- Subject is less than 18 years old at time of screening.Disease-Related- Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP.

Disease Related- Subject has or previously had any 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).- Subject has any new active malignancy diagnosed since enrollment in the previous romiplostim ITP study.Medications- Subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study.General- Other investigational medications are excluded.- Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).- Subject (male or female) is not willing to use highly effective contraception during treatment if and when sexually active and for 4 weeks (women) or 14 weeks (men) after the end of treatment.- Subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment.- Male subject with a pregnant partner who is not willing to use a condom if and when sexually active during treatment and for 14 weeks after the end of treatment.- Subject has known sensitivity to any of the products to be administered during dosing.- Subject previously has entered this study (this will depend on the type of study).- Subject will not be available for protocol-required study visits, to the best of the subject and investigator?s knowledge.- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

The primary endpoints are the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation.

  DISEÑO DEL ENSAYO:

Si
No

Si
No

No
No

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
Si

No

Centros participantes:

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

2
11
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


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

Rango de edad:

1
0

0

Sexo:

1
1

Número planeado de pacientes a incluir:

2

Para estudios internacionales:


20

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 EC Finalizado



EC Finalizado