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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. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Shandong
      • Liaocheng, Shandong, China, 252000
        • Forest ecological agriculture
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21287
        • Forest ecological agriculture

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Allergic reaction (IgA) vasculitis
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2028

Studienabschluss (Geschätzt)

1. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

24. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Art der unterstützenden IPD-Freigabeinformationen

  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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