- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00128882
Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D
Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
Idiopathic thrombocytopenic purpura (ITP) in children is considered a benign hematological disease. The incidence is approximately 50 cases a year in Denmark. Approximately 25 % will experience chronic disease. Follow up and treatment of these patients is not centralized.
The drug of choice is intravenous IgG (IVIG) for treatment of ITP. The side effects are flu-like symptoms, and in rare cases aseptic meningitis. Another option is intravenous anti-D, if the child is rhesus positive. Anti-D is primarily used in North America. The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50,000/μL. Anti-D also causes flu-like symptoms. Establishing an i.v. access is a disadvantage to both IVIG and anti-D. For both treatments mechanism of action is not finally described.
Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia. It is therefore known, that immunoglobulin uptake is possible after subcutaneous administration. Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results.
IVIG treatment is expensive compared to anti-D. Treatment of a 20 kg child costs approximately 17,000 Dkr for IVIG and 2,500 Dkr. for anti-D.
Hypothesis:
- Subcutaneous administered anti-D is as effective as IVIG/i.v. anti-D;
- Subcutaneous administered anti-D has fewer less severe side effects than IVIG/i.v. anti-D.
Purpose:
- To document the effect of subcutaneous anti-D;
- Describe complications;
- Describe aspects of the mechanism of action.
Material and Methods:
Children are eligible if admitted to a pediatric department in Denmark for diagnosis, observation or treatment of acute or chronic ITP. Examination and diagnostic work up is similar throughout the country, but not identical. No specific tests are required for diagnosis. If treatment is indicated rhesus positive children are treated with subcutaneous anti-D. Rhesus negative children are treated according to local guidelines. Specified follow-up on all children is mandatory. For research purposes one blood sample form all children is collected, and from children, who receive medical treatment, several blood samples are collected. Analysis for changes in immunological signaling peptides will be performed with special attention to the mechanism of action of anti-D.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Aalborg, Dinamarca, 9100
- Aalborg University Hospital, Department of Pediatrics
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Aarhus N, Dinamarca, 8200
- Skejby Hospital, Aarhus University Hospital, Department of Pediatrics
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Copenhagen S, Dinamarca, 2300
- Amager Hospital, Department of Pediatrics
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Copenhagen Ø, Dinamarca, 2100
- Rigshospitalet, Copenhagen University Hospital, Pediatric Clinic II
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Esbjerg, Dinamarca, 6700
- Esbjerg Hospital, Department of Pediatrics
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Gentofte, Dinamarca, 2900
- Gentofte Hospital, Department of Pediatrics
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Herning, Dinamarca, 7400
- Herning Hospital, Department of Pediatrics
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Hjoerring, Dinamarca, 9800
- Hjoerring Hospital, Department of Pediatrics
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Holbæk, Dinamarca, 4300
- Holbæk Hospital, Department of Pediatrics
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Hvidovre, Dinamarca, 2650
- Hvidovre Hospital, Department of Pediatrics
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Kolding, Dinamarca, 6000
- Kolding Hospital Department of Pediatrics
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Nykøbing F, Dinamarca, 4800
- Nykøbing F, Department of Pediatrics
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Næstved, Dinamarca, 4700
- Næstved Hospital, Department of Pediatrics
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Odense C, Dinamarca, 5000
- Odense University Hospital
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Randers, Dinamarca, 8900
- Randers Hospital, Department of Pediatrics
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Sønderborg, Dinamarca, 6400
- Sønderborg Hospital, Department of Pediatrics
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Viborg, Dinamarca, 8800
- Viborg Hospital, Department of Pediatrics
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Idiopathic thrombocytopenic purpura (ITP)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Clinical effect evaluated on clinical score scale before and after treatment at specified intervals
Periodo de tiempo: day 0,1,3,6,14,30, 180,360
|
day 0,1,3,6,14,30, 180,360
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Platelet count
Periodo de tiempo: day 0, 1, 3, 6, 14, 30, 180, 360
|
day 0, 1, 3, 6, 14, 30, 180, 360
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Mimi Kjaersgaard, MD, University of Aarhus, Clinical Institute, Department of Pediatrics
- Investigador principal: Henrik Hasle, MD PhD, Skejby Hospital, University of Aarhus, Department of Pediatrics
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades hematológicas
- Hemorragia
- Trastornos hemorrágicos
- Trastornos de la coagulación de la sangre
- Manifestaciones de la piel
- Trombocitopenia
- Trastornos de las plaquetas sanguíneas
- Microangiopatías trombóticas
- Púrpura
- Púrpura Trombocitopénica
- Púrpura Trombocitopénica Idiopática
Otros números de identificación del estudio
- MK-2005-1
- 2003179
- 2612-2447
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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