- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00166387
Hemophilia Inhibitor Genetics Study (HIGS)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Malmo, Suecia, SE-205 02
- Malmö University Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Severe hemophilia A is defined as a baseline factor VIII level <1%. A history of inhibitor is defined as ever having a Bethesda titer > 1 BU.
Phase I.
Subjects with hemophilia are eligible for Phase I of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject has severe hemophilia A.
- The subject has a history of inhibitor or the subject has no history of inhibitor but has at least 100 exposure days to factor VIII products.
- Sufficient documentation exists to identify the subject's maximum lifetime Bethesda titer.
- The subject has a history of inhibitor and has one or more full brothers with severe hemophilia A, with or without an inhibitor, who are eligible for and have agreed to be in the study, and two parents who have agreed to be in the study or the subject does not have a history of inhibitor but has one or more full brothers with severe hemophilia A and a history of inhibitor who are eligible for and have agreed to be in the study, and two parents who have agreed to be in the study.
Subjects without hemophilia are eligible for Phase I of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject is the parent (mother or father) of, or the full sibling of, a subject with hemophilia who is eligible for Phase I of the study.
Phase II.
Subjects with hemophilia are eligible for Phase II of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject has severe hemophilia A.
- The subject has a history of inhibitor and two parents who have agreed to be in the study.
- Sufficient documentation exists to identify the subject's maximum lifetime Bethesda titer.
Subjects without hemophilia are eligible for Phase II of the study if all of the following apply:
- An informed consent form, approved by the appropriate IRB/IEC, has been administered, signed, and dated.
- The subject is the parent (mother or father) of a subject with hemophilia who is eligible for Phase II of the study.
Exclusion Criteria:
Phase I.
Subjects (with or without hemophilia) are excluded from participation in Phase I if:
- The minimum family group, defined as a pair of full brothers with hemophilia, either concordant (both with) or discordant (one with, one without) for inhibitor, and both of their parents, is not enrolled.
Phase II.
Subjects are excluded from participation in Phase II if:
- The minimum family group, defined as a person with hemophilia and a history of inhibitor and his mother and father, is not enrolled.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Phase I, II, III
Phase I consists of a brother pair with hemophilia, one or both of whom has a history of inhibitors, and their parents; Phase II consists of a person with hemophilia and an inhibitor, and both his parents; Phase III consists of an unrelated group of people with hemophilia.
|
A single blood draw.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
development of inhibitory antibodies to factor VIII
Periodo de tiempo: upon development of inhibitor or following at least 100 exposure days to factor VIII
|
upon development of inhibitor or following at least 100 exposure days to factor VIII
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Erik Berntorp, MD, PhD, Skåne University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Berntorp E, Astermark J, Donfield SM, Nelson GW, Oldenburg J, Shapiro AD, Dimichele DM, Ewenstein BM, Gomperts ED, Winkler CA; Hemophilia Inhibitor Genetics Study. Haemophilia Inhibitor Genetics Study - evaluation of a model for studies of complex diseases using linkage and association methods. Haemophilia. 2005 Jul;11(4):427-9. doi: 10.1111/j.1365-2516.2005.01119.x. No abstract available.
- Astermark J, Donfield SM, Gomperts ED, Schwarz J, Menius ED, Pavlova A, Oldenburg J, Kessing B, DiMichele DM, Shapiro AD, Winkler CA, Berntorp E; Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. The polygenic nature of inhibitors in hemophilia A: results from the Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. Blood. 2013 Feb 21;121(8):1446-54. doi: 10.1182/blood-2012-06-434803. Epub 2012 Dec 6.
- Schwarz J, Astermark J, Menius ED, Carrington M, Donfield SM, Gomperts ED, Nelson GW, Oldenburg J, Pavlova A, Shapiro AD, Winkler CA, Berntorp E; Hemophilia Inhibitor Genetics Study Combined Cohort. F8 haplotype and inhibitor risk: results from the Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. Haemophilia. 2013 Jan;19(1):113-8. doi: 10.1111/hae.12004. Epub 2012 Sep 7.
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
Otros números de identificación del estudio
- HIGS
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. .
Ensayos clínicos sobre Blood draw
-
University Hospital, RouenAún no reclutandoHepatitis B | Hepatitis C | SIDAFrancia
-
Haydarpasa Numune Training and Research HospitalTerminadoDesorden sangrantePavo
-
Smiths Medical, ASD, Inc.Terminado
-
Applied Science & Performance InstituteTerminadoDeficiencia de hierro (sin anemia)Estados Unidos
-
Ischemia Care LLCTerminadoAccidente cerebrovascular isquémico | Fibrilación auricular | Accidente cerebrovascular trombótico | Ataques isquémicos transitorios | Accidente cerebrovascular cardioembólico | Accidente cerebrovascular de la arteria basilar | Eventos cerebrovasculares transitoriosEstados Unidos
-
Tan Tock Seng HospitalMayo ClinicDesconocidoSepticemia | Fungemia | Bacteriemia | Infección del torrente sanguíneoSingapur
-
University of California, IrvineNational Heart, Lung, and Blood Institute (NHLBI)ReclutamientoHipertensión | Adherencia a la medicaciónEstados Unidos
-
University Hospital, Clermont-FerrandCentre Jean PerrinDesconocidoAsincronía Ventricular IzquierdaFrancia
-
University of Maryland, BaltimoreTerminadoDeficiencia de hierro no anémicaEstados Unidos
-
Reham HassanTerminadoEfectos de los ElementosEgipto