Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Avacopan.
- Who it may be relevant to
- Registry conditions: Diffuse Alveolar Hemorrhage, Antineutrophil Cytoplasmic Antibody Positive Vasculitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetics Of Emulsified Avacopan In ANCA-associated Vasculitis With Severe Diffuse Alveolar Hemorrhage
Overview
The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for respiratory support.
Interventions
- Drug Avacopan
Avacopan capsules will be solubilized in heated water and administered to patients with Diffuse Alveolar Hemorrhage (DAH) due to GPA or MPA via nasogatric tube.
Primary outcome measures
- Change in Avacopan blood level over time [Time frame: 72 hours]
Secondary outcome measures (1)
- Measure in Markers of Neutrophil Activation on Serum Samples [Time frame: 72 hours]
Eligibility criteria
Inclusion criteria
- Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA).
- Positivity for ANCA, directed against PR3 or MPO.
- Diffuse alveolar hemorrhage.
- Respiratory failure requiring mechanical ventilation.
- Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary.
- Minimum BVAS-WG of 3.
- Requirement of standard-of-care remission induction therapy for active severe ANCA-associated vasculitis (GPA or MPA).
Exclusion criteria
- Diagnosis with eosinophilic granulomatosis with polyangiitis (EGPA, formally Churg-Strauss syndrome) as defined by the Chapel Hill consensus conference.
- Allergies: History of severe allergic reaction to avacopan
- History of documented anti-glomerular basement membrane disease (anti-GBM disease)
- Previous administration of avacopan within the last 5 days.
- Concomitant use of a strong CYP3A4 inhibitor.
- Aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\], alkaline phosphatase, or total bilirubin elevation >2.5 times the upper limit of normal (unless attributed to vasculitis) on routine liver function testing obtained within 3 days prior to anticipated treatment with avacopan.
- Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection.
- Active serious infection, including localized infection.
- Pregnancy and breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07556484 · 24-009571