- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21287
- Forest ecological agriculture
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Shandong
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Liaocheng, Shandong, Čína, 252000
- Forest ecological agriculture
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Allergic reaction (IgA) vasculitis
Časové okno: 7 days
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7 days
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BBD-1
- Funding BBD-1 (Jiný identifikátor: Forest Ecological Agriculture (Liaocheng) Co., Ltd)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Typ podpůrných informací pro sdílení IPD
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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