- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00504075
A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Buenos Aires, Argentina, C1280AEB
- Hospital Británico
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Buenos Aires, Argentina, C1122AAL
- I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento)
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Buenos Aires, Argentina, C1431FWO
- Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC)
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Cordoba, Argentina, X5016KEH
- Hospital Privado de Cordoba
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Corrientes, Argentina
- J.R. Vidal Hospital
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San Juan, Argentina, 5400
- CER San Juan
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1437JCP
- Hospital Churruca
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La Plata, Buenos Aires, Argentina, B1900AXU
- Hospital Italiano de La Plata
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Sante Fe
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Rosario, Sante Fe, Argentina, S2000JKR
- Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA)
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Florida
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Orange City, Florida, Estados Unidos, 32763
- Mid Florida Hematology & Oncology
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Maryland
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Bethesda, Maryland, Estados Unidos, 20817
- Center for Cancer & Blood Disorders
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New York
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New York, New York, Estados Unidos, 10021
- New York Hospital / Cornell University, Division of Pediatrics
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Stony Brook, New York, Estados Unidos, 11794-8111
- Department of Pediatrics, SUNY at Stony Brook
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Cancer Care Centers of South Texas
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New Delhi, India, 110060
- Sir Ganga Ram Hospital
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500003
- Apollo Hospitals
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Hyderabad, Andhra Pradesh, India, 500054
- Mahavir Hospital
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Suryarao pet, Vijayawada, Andhra Pradesh, India, 520002
- City Cancer Centre,
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Bangalore
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Karnataka, Bangalore, India, 560054
- M. S Ramaiah Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380009
- Vedanta
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Ahmedabad, Gujarat, India, 380061
- Gurukrupa Hospital
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Gokal Nagar, Karamsad, Gujarat, India, 388325
- M S Patel Cancer Centre, Shree Krishna Hospital
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Karnataka
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Bangalore, Karnataka, India, 560017
- Manipal Hospital
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Mangalore, Karnataka, India, 575002
- Father Muller Medical College Hospital
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Mangalore, Karnataka, India, 5750003
- Vinaya Hospital & research Centre
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Mangalore, Karnataka, India, 575001
- Kasturba Medical College, Manipal Acunova KMC Research Centre
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Maharashtra
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Pune, Maharashtra, India, 411004
- Deenanath Mangeshkar Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 300201
- S.K. Soni Hospital Sect 5
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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:
- Males and females aged between 18 and 70 years.
- Confirmed diagnosis of chronic ITP of at least 6 months duration.
- Platelet count of less than or equal to 20 x 10 9/L at enrollment.
- Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
- If subjects were treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before screening). The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 6) If subjects were being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before Day 1. The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 7) Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included.
8) The subject has signed an informed consent form (subjects must be at least 18 years old), and/or the subject's legal guardian has signed the informed consent form if indicated 9) If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.
10) If a subject is a female who is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.
Exclusion Criteria:
- A history of any severe or anaphylactic reaction to blood or any blood-derived product, or any severe reaction to IGIV or any other IgG preparation.
- Intolerance to any component of the investigational product.
- Received any live virus vaccine within the last 3 months prior to Day1.
- Received an IGIV preparation within 1 month prior to Day 1.
- Were currently receiving, or has received, any investigational agent within the 1 month prior to Day 1.
- Received any blood, blood product, or blood derivative within the 1 month prior to Day 1.
- Received Rituximab within the 3 months before Day 1.
- Pregnant or nursing.
- Tested positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
- Had levels greater than 2.5 times the upper limit of normal at screening, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.
- Had severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); on dialysis; a history of acute renal failure.
- Known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
- History of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
- Any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
- Suffered from any acute or chronic medical conditions (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the investigator, may interfere with the conduct of the study.
- An acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an absolute neutrophil count (ANC) < 1 x 109/L).
- Non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg).
- Anemic (hemoglobin <10 g/dL) at screening.
- Unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Gammaplex (intravenous immunoglobulin)
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Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG). The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.
Periodo de tiempo: 9 days
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The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.
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9 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Safety of GAMMAPLEX at the Dosage Used in This Study.
Periodo de tiempo: AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
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The safety variables used to assess safety were the following:
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AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
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Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.
Periodo de tiempo: Days 1, 2, 3, 5, 9, 14, 21, 32.
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Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.
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Days 1, 2, 3, 5, 9, 14, 21, 32.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tim J Aldwinckle, MD, Bio Products Laboratory
Publicaciones y enlaces útiles
Enlaces Útiles
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
- Efectos fisiológicos de las drogas
- Factores inmunológicos
- Anticuerpos
- Inmunoglobulinas
- Inmunoglobulinas, Intravenosas
- gamma-globulinas
- Inmunoglobulina Rho(D)
Otros números de identificación del estudio
- GMX02
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 Gammaplex, intravenous immunoglobulin
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Bio Products LaboratoryTerminadoInmunodeficiencia Común Variable | Trastornos de inmunodeficiencia primaria | Síndrome de Hiper-IgM | Agammaglobulinemia ligada al XEstados Unidos, Reino Unido, Hungría
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Braintree LaboratoriesTerminado
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Bio Products LaboratoryTerminadoInmunodeficiencia Primaria | Síndrome de Wiskott-Aldrich | Hipogammaglobulinemia | Hipogammaglobulinemia variable común | Hipogammaglobulinemia ligada al cromosoma X | Inmunodeficiencia Con Hiper-IgMEstados Unidos
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Bio Products LaboratoryTerminadoInmunodeficiencia Común Variable | Síndrome de Wiskott-Aldrich | Agammaglobulinemia ligada al X | Trastornos de inmunodeficiencia primaria | Síndrome de Hiper-IgMEstados Unidos, Chile, Israel
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Isaac MelamedBio Products LaboratoryDesconocidoTrastorno autista | Autismo | Trastorno de Asperger | Trastorno generalizado del desarrollo | DPDEstados Unidos
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Prometic Biotherapeutics, Inc.Atlantic Research GroupTerminadoInmunodeficiencia PrimariaEstados Unidos