- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07595367
Evaluate the Effectiveness and Safety of BBD-1 Multi-target Immune Enhancement Targeting Agent in the Treatment of Hypersensitivity Reaction (IgA) Vasculitis
Evaluate the Effectiveness and Safety of BBD-1 Multi-target Immune Enhancement Targeting Agent in the Treatment of Hypersensitivity Reaction (IgA) Vasculitis Compare the Efficacy of BBD-1 Multi-target Immune Enhancement Targeting Agent With Glucocorticoids, Providing Reference for the Registration of BBD-1 Multi-target Immune Enhancement Targeting Agent and the Rational and Standardized Use of BBD-1 Multi-target Immune Enhancement Targeting Agent by Clinical Doctors in the Future
Hypersensitivity (IgA) vasculitis is a common vascular allergic disease, the cause of which is not yet clear, and may involve infection, immune disorders, heredity and other factors. It belongs to the category of immune diseases. The disease can be divided into simple type, abdominal type, joint type, renal type and mixed type allergic purpura according to the location of the disease. The annual incidence rate is about 6.1 to 55.9 cases per 100000 people. The highest incidence rate is among children aged 2 to 6 years. When the kidneys are affected, this condition is called IgAV nephritis (IgAVN), affecting approximately 20% to 80% of IgAV patients, making it one of the most common secondary glomerular diseases in this population. At the same time, skin redness, itching, and joint pain caused by hypersensitivity reaction (IgA) vasculitis also seriously affect the quality of life of patients.
Most IgAVN cases are mild or self limiting; However, some patients may experience severe kidney involvement, manifested as nephrotic syndrome, significant proteinuria, elevated serum creatinine levels, hypertension, persistent proteinuria, and kidney biopsy results showing more than 50% crescent shaped involvement. Research has shown that approximately 10% to 20% of patients with moderate to severe proteinuria caused by IgAVN may develop end-stage renal disease (ESRD), and persistent proteinuria has been identified as an independent risk factor for poor prognosis of IgAVN. At present, clinical treatment mainly relies on nonsteroidal anti-inflammatory drugs, glucocorticoids, anti allergic and antihistamines, anticoagulants, corticosteroids, calcineurin inhibitors (CNI), mycophenolate mofetil (MMF), cyclophosphamide (CTX), and other immunosuppressants. However, some patients may not respond well to conventional treatment, and long-term use of these drugs may lead to various adverse reactions, including infections, metabolic disorders, and growth disorders.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hypersensitivity (IgA) vasculitis is a common vascular allergic disease, the cause of which is not yet clear, and may involve infection, immune disorders, heredity and other factors. It belongs to the category of immune diseases. The disease can be divided into simple type, abdominal type, joint type, renal type and mixed type allergic purpura according to the location of the disease. The annual incidence rate is about 6.1 to 55.9 cases per 100000 people. The highest incidence rate is among children aged 2 to 6 years. When the kidneys are affected, this condition is called IgAV nephritis (IgAVN), affecting approximately 20% to 80% of IgAV patients, making it one of the most common secondary glomerular diseases in this population. At the same time, skin redness, itching, and joint pain caused by hypersensitivity reaction (IgA) vasculitis also seriously affect the quality of life of patients.
Because BBD-1 multi-target immune enhancer targeting agent is a natural plant compound, no adverse reactions have been found so far.
Most IgAVN cases are mild or self limiting; However, some patients may experience severe kidney involvement, manifested as nephrotic syndrome, significant proteinuria, elevated serum creatinine levels, hypertension, persistent proteinuria, and kidney biopsy results showing more than 50% crescent shaped involvement. Research has shown that approximately 10% to 20% of patients with moderate to severe proteinuria caused by IgAVN may develop end-stage renal disease (ESRD), and persistent proteinuria has been identified as an independent risk factor for poor prognosis of IgAVN. At present, clinical treatment mainly relies on nonsteroidal anti-inflammatory drugs, glucocorticoids, anti allergic and antihistamines, anticoagulants, corticosteroids, calcineurin inhibitors (CNI), mycophenolate mofetil (MMF), cyclophosphamide (CTX), and other immunosuppressants. However, some patients may not respond well to conventional treatment, and long-term use of these drugs may lead to various adverse reactions, including infections, metabolic disorders, and growth disorders.
Existing research has confirmed that BBD-1 multi-target immune enhancement targeting agent is effective and safe in treating hypersensitivity reaction (IgA) vasculitis. After one hour of intervention therapy with BBD-1 multi-target immune enhancement targeting agent, itching basically disappeared and pain was significantly reduced. After 24 hours, the purpura became lighter, and after 48 hours, the purpura became significantly lighter. After 72 hours, the purpura basically disappeared, and after 96 hours, it reached the clinical cure standard.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Forest ecological agriculture
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Shandong
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Liaocheng, Shandong, Porcelana, 252000
- Forest ecological agriculture
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Medically confirmed hypersensitivity vasculitis with IgA deposition IgA vasculitis
- Purpura and/or involvement of at least one organ in the kidneys, joints, or intestines
Exclusion criteria:
- Participate in another intervention trial
- The patient did not sign the informed consent form
- Patients without social security insurance
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: Allergic reaction (IgA) vasculitis
Existing research has confirmed that BBD-1 multi-target immune enhancement targeting agent is effective and safe in treating hypersensitivity reaction (IgA) vasculitis.
After one hour of intervention therapy with BBD-1 multi-target immune enhancement targeting agent, itching basically disappeared and pain was significantly reduced.
After 24 hours, the purpura became lighter, and after 48 hours, the purpura became significantly lighter.
After 72 hours, the purpura basically disappeared, and after 96 hours, it reached the clinical cure standard.
|
Existing research has confirmed that BBD-1 multi-target immune enhancement targeting agent is effective and safe in treating hypersensitivity reaction (IgA) vasculitis.
After one hour of intervention therapy with BBD-1 multi-target immune enhancement targeting agent, itching basically disappeared and pain was significantly reduced.
After 24 hours, the purpura became lighter, and after 48 hours, the purpura became significantly lighter.
After 72 hours, the purpura basically disappeared, and after 96 hours, it reached the clinical cure standard.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Allergic reaction (IgA) vasculitis
Periodo de tiempo: 7 days
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7 days
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- BBD-1
- Funding BBD-1 (Otro identificador: Forest Ecological Agriculture (Liaocheng) Co., Ltd)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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 Allergic Reaction (IgA) Vasculitis
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Grit BiotechnologyShanghai Zhongshan HospitalAún no reclutandoNefropatía membranosa | Nefropatía por IgA (IgAN) | Glomerulonefritis proliferativa con depósitos de inmunoglobulina monoclonal | Vasculitis Asociada a ANCA (AAV)/Glomerulonefritis Asociada a ANCA (AAGN) | Podocitopatía RefractariaPorcelana
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The Children's Hospital of Zhejiang University...ReclutamientoEnfermedades autoinmunes | Nefropatía por IgA (IgAN) | Vasculitis sistémica asociada a ANCA | Esclerosis Sistémica (ESc) | Síndrome nefrótico resistente a múltiples fármacos | Lupus Erthematoso sistémico (LES)Porcelana
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The Children's Hospital of Zhejiang University...ReclutamientoEnfermedades autoinmunes | Nefropatía por IgA (IgAN) | Vasculitis sistémica asociada a ANCA | Esclerosis Sistémica (ESc) | Síndrome nefrótico resistente a múltiples fármacos | Lupus Erthematoso sistémico (LES)Porcelana
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Guixia DingAún no reclutando
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Christian Medical College, Vellore, IndiaMedical Research Council; India AllianceReclutamientoInsuficiencia Renal Crónica | Nefropatía por IgA | IGA Glomerulonefritis | Vasculitis IgAIndia
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Assistance Publique - Hôpitaux de ParisReclutamiento
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Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; Ministry of... y otros colaboradoresAún no reclutandoNefropatías diabéticas | Nefropatía por IgA | Vasculitis asociada a ANCA | Glomerulopatía extramembranosa | Síndrome Nefrótico, Cambio Mínimo | Nefritis intersticial | Hialinosis segmentariaFrancia
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The Children's Hospital of Zhejiang University...Aún no reclutandoVasculitis IgA | Igavn
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The Children's Hospital of Zhejiang University...ReclutamientoEnfermedades autoinmunes | Nefropatía por IgA (IgAN) | Vasculitis sistémica asociada a ANCA | Esclerosis Sistémica (ESc) | Síndrome nefrótico resistente a múltiples fármacos | Lupus Erthematoso sistémico (LES)Porcelana
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University of PennsylvaniaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Center for Advancing Translational Sciences (NCATS) y otros colaboradoresReclutamientoVasculitis IgA | Púrpura de Henoch-Schönlein | Poliarteritis Nodosa Cutánea | Vasculitis cutánea primariaEstados Unidos, Canadá, Japón