- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00244257
Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
8 de abril de 2015 actualizado por: Genzyme, a Sanofi Company
Phase I, Open-Label, Multi-center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
This study is designed to investigate the safety of a single infusion of GMA161 in patients with idiopathic thrombocytopenic purpura, as well as, the way the drug enters and leaves the body.
In addition, throughout the study, platelet counts and other blood cell numbers will be measured.
NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
10
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90033
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San Diego, California, Estados Unidos, 92121
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
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New York
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New York, New York, Estados Unidos, 10021
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Willing and able to provide written informed consent prior to any study-related procedures
- Chronic idiopathic thrombocytopenic purpura diagnosed for at least 6 months
- A platelet count of < 100,000/mm^3 on 2 determinations at least 6 weeks apart, including 1 determination within 7 days prior to initiating study treatment. Patients on a stable dose of corticosteroids for 2 weeks prior to study entry and with a platelet count of < 100,000/mm^3 may be enrolled
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1, with a life expectancy of at least 6 months
Exclusion Criteria:
- Women who are pregnant or lactating
- Women of childbearing potential unless using a medically acceptable contraceptive precaution with the use of spermicide or are sexually inactive
- Women who plan to become pregnant within 6 months after the screening phase
- Evidence of excessive bleeding requiring hospitalization within 6 weeks of study entry or a red cell transfusion within 6 weeks of study entry
- Absolute neutrophil count < 2,000/mm^3
- Total bilirubin > 2 mg/dL or alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times the upper limit of normal ranges in the institutional laboratory
- Creatinine > 2 mg/dL
- History of drug-induced thrombocytopenia, marrow failure syndrome, such as aplastic anemia or myelodysplasia, or thrombocytopenia related to viral or bacterial infection
- Elevated (≥ 1.5 times the upper limit of normal range) prothrombin time (PT) or partial thromboplastin time (PTT) (other than related to a lupus anticoagulant or contact factor defect)
- Evidence of active bacterial infection or viral infection
- Active hemolysis that requires red cell transfusion within 6 weeks of study entry (Patients with evidence of concurrent autoimmune hemolysis [Evan's Syndrome] will be allowed)
- History of clinically significant cardiac or pulmonary disease
- History of cancer, other than: basal cell skin cancer, squamous cell skin cancer with no previous chemotherapy treatment or disease-free carcinoma in situ of the cervix, for a minimum of 5 years from the time of Screening
- HIV infection or acute or persistent hepatitis B and C viral infection (characterized by positive hepatitis B surface antigen (HBsAg), positive anti-hepatitis C virus [HCV] or polymerase chain reaction [PCR] assays for HCV)
- History of concurrent autoimmune disorders requiring systemic treatment for involvement of organ systems other than cytopenias or thyroid disease
- Treatment with cyclophosphamide, vincristine, rituximab, or any other monoclonal antibody within 12 weeks of study infusion
- Treatment with intravenous immunoglobulin (IVIg) within 2 weeks of study drug infusion or Rh(D) immune globulin intravenous within 4 weeks of study drug infusion
- Treatment with an agent, other than IVIg or corticosteroids, for ITP within 4 weeks of study entry. The dose level of corticosteroids may not be increased or decreased within 2 weeks of study entry
- Use of any investigational drug within 12 weeks before Screening
- Other pathology that might interfere with the assessment of the safety or efficacy of the test article or other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.
- Patients who have been splenectomized within 2 months of study entry.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
Cohorte 1
|
0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
|
Experimental: 2
Cohorte 2
|
0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
|
Experimental: 4
Cohorte 4
|
0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
|
Experimental: 3
Cohort 3
|
0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
|
Experimental: 5
Cohort 5
|
0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Evaluate safety, tolerability and pharmacokinetics (PK) of single intravenous (IV) infusions of GMA161 in patients with idiopathic thrombocytopenic purpura (ITP)
Periodo de tiempo: up to 3 years
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up to 3 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2005
Finalización primaria (Actual)
1 de julio de 2008
Finalización del estudio (Actual)
1 de julio de 2008
Fechas de registro del estudio
Enviado por primera vez
25 de octubre de 2005
Primero enviado que cumplió con los criterios de control de calidad
25 de octubre de 2005
Publicado por primera vez (Estimar)
26 de octubre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de abril de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
8 de abril de 2015
Última verificación
1 de abril de 2015
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
- GMA16100104
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. .