- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Forest ecological agriculture
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Shandong
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Liaocheng, Shandong, Kina, 252000
- Forest ecological agriculture
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Allergic reaction (IgA) vasculitis
Tidsramme: 7 days
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7 days
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BBD-1
- Funding BBD-1 (Anden identifikator: Forest Ecological Agriculture (Liaocheng) Co., Ltd)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Allergic Reaction (IgA) Vasculitis
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Alexion Pharmaceuticals, Inc.RekrutteringImmunoglobulin A nefropati | IgAN | IgA vaskulitis | Igavn | Immunoglobulin A Vasculitis Associated Nephritis | Henoch-Schonlein purpura nefritisForenede Stater, Spanien, Italien, Taiwan, Kina, Japan, Sydkorea
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Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... og andre samarbejdspartnereIkke rekrutterer endnuDiabetiske nefropatier | IgA nefropati | ANCA Associated Vasculitis | Ekstramembranøs glomerulopati | Nefrotisk syndrom, minimal ændring | Interstitiel nefritis | Segmental hyalinoseFrankrig