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Evaluate the Effectiveness and Safety of BBD-1 Multi-target Immune Enhancement Targeting Agent in the Treatment of Hypersensitivity Reaction (IgA) Vasculitis

14 maja 2026 zaktualizowane przez: Qifeng Zhang

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.

Przegląd badań

Status

Rejestracja na zaproszenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Shandong
      • Liaocheng, Shandong, Chiny, 252000
        • Forest ecological agriculture
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21287
        • Forest ecological agriculture

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion criteria:

  1. Medically confirmed hypersensitivity vasculitis with IgA deposition IgA vasculitis
  2. Purpura and/or involvement of at least one organ in the kidneys, joints, or intestines

Exclusion criteria:

  1. Participate in another intervention trial
  2. The patient did not sign the informed consent form
  3. Patients without social security insurance

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Allergic reaction (IgA) vasculitis
Ramy czasowe: 7 days
  1. The disappearance of palpable purpura is a direct manifestation of recovery. Observe whether there are new subcutaneous bleeding points on the patient's body, and whether the original purpura color gradually changes from purple red to yellow brown until it disappears. Some patients may have temporary pigmentation, but it will not continue to expand or recur.
  2. Joint pain disappears. Patients with hypersensitivity reaction (IgA) vasculitis answered in the questionnaire that the swollen joint pain was relieved and their mobility was restored, indicating that the inflammation was under control. Diagnosis can also be made through C-reactive protein testing.
  3. No proteinuria (24-hour urine protein below 0.4g/24 hours). Urine routine examination can detect protein indicators in urine to evaluate kidney function.
  4. The serum albumin level is 35g-55g/L. Serum creatinine is below 1.24mg/dL. Perform blood biochemical tests on serum albumin and serum creatinine to evaluate renal function.
7 days

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

24 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • BBD-1
  • Funding BBD-1 (Inny identyfikator: Forest Ecological Agriculture (Liaocheng) Co., Ltd)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Typ informacji pomocniczych dotyczących udostępniania IPD

  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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