Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies.

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Resumen

2017-03-15 03:56:38
2005-000043-28
E05-001
A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies.
E05 Extension
E05-001

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
ALEXION PHARMACEUTICALS INCORPORATED United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
eculizumab
Solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

h5G1.1-mAb Anti-C5 antibod

Concentración del fármaco:

mg/ml milligram equal

10

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
Si

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Solution for infusion

Intravenous use

Información General



Anemias, Insuficiencias Medulares

paroxysmal nocturnal hemoglobinuria


The primary objective is to evaluate the long-term safety of eculizumab in patients with transfusion-dependent hemolytic PNH.

Secondary endpoints will include: hemolysis as measured by lactate dehydrogenase (LDH) area under the curve (AUC); Quality of Life (QoL) as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FACIT-F SCALE)); and incidence of thrombosis.

Information no disponible en EudraCT


1. Patients have fully completed the TRIUMPH (C04-001), SHEPHERD (C04-002), or X03-001 studies, or, TRIUMPH patients who have discontinued receiving investigational product prior to the Visit 18 due to lack of efficacy or exacerbation of symptoms of PNH and have completed, at minimum, all efficacy and safety procedures at Visits 4, 5, 6, 7, 9, 11, 13, 15, 17 and 18. 2. Patient must be willing and able to give written informed consent.3. Patient must avoid conception during the trial using a method that is most appropriate for their physical state and culture.

1. Patients who have early terminated from the SHEPHERD (C04-002) or X03- 001 studies;2. Patients who have withdrawn from the TRIUMPH study (C04-001) due to an adverse event;3. Females: pregnant, breast-feeding, or intending to conceive during the course of the study, including the Safety Follow-up Visits;4. Any condition that, in the opinion of the Investigator, could increase the patient’s risk by participating in the study or confound the outcome of the study.

Primary endpoints are treatment-emergent adverse events (AEs), clinical laboratory and electrocardiogram data, and vital signs. These data will be summarized for safety-evaluable patients. Adverse events will be assigned MedDRA? preferred terms and tabulated as incidence rates.

Fase III
  DISEÑO DEL ENSAYO:

No
No

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
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
0
  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:


25

Para estudios internacionales:


85
170

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado