EUCTR2021-004706-22-DE招募中1 期
Imlifidase in ANCA-associated vasculitis - ImlifidARDSe
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.New or previous clinical diagnosis of ANCA-associated vasculitis, (granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) consistent with revised Chapel Hill definitions
- •2.ANCA titer >= 50 (AU/ml) (i.e. anti-myeloperoxidase / anti-proteinase 3) no more than 14 days prior to inclusion measured by certified clinical laboratory
- •3.Pulmonary hemorrhage due to active vasculitis defined by the following:
- •oA compatible chest x-ray or CT scan (diffuse pulmonary infiltrates)
- •oThe absence of an alternative explanation for all pulmonary infiltrates (i.e. volume overload or pulmonary infection)
- •oAt least one of the following:
- •?Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage
- •?Observed hemoptysis
- •?Unexplained anemia (<10 g/dL) or documented drop in hemoglobin (>1 g/dL) from less than 10g/dl
- •?Acute respiratory distress syndrome (ARDS, according to Berlin definition)
- •4.Provision of written informed consent by patients before any study related procedure
- •5.Willingness and ability to comply with the protocol
- •6.For female subjects: Confirmed post-menopausal state (defined as amenorrhea for at least 12 months)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Subjects aged < 18 or > 80 years
- •2.Subjects physically or mentally unable to give written informed consent
- •3.Subjects deprived of freedom i.e., detainment or commitment to psychiatric ward, prison or state institution by law court or legal authority
- •4.Female subjects: pregnant or breastfeeding or of childbearing potential
- •5.Male subjects: unwilling to use double-barrier contraception for the duration of this study.
- •6.Concomitant autoimmunological disease (e.g. Goodpasture, vasculitis other than AAV)
- •7.Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) consistent with revised Chapel Hill definitions
- •8.Concomitant pulmonary disease (e.g. chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD))
- •9.Known allergy/sensitivity to imlifidase, IVIg and/or the respective excipients
- •10.Previous treatment with imlifidase
- •11.Previous or ongoing high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
- •12.More than two plasma exchanges prior to administration of imlifidase within 28 days prior to inclusion
- •13.Participation in an other interventional clinical trial or intake of other investigational medicinal product within 5 half-lives (or similar) of the product prior to inclusion
- •14.Symptomatic congestive heart failure (NYHA class 2-4) requiring prescription medication or clinically evident peripheral edema of cardiac origin or documented evidence/history of NYHA class 2-4 heart failure
- •15.A comorbidity or indication of such based on medical history, physical examination, and clinical laboratory assessments which precludes the use of cyclophosphamide, glucocorticoids, or imlifidase.
- •16.Evidence of moderate or severe hepatic impairment indicated by elevated aminotransferases (ALT or AST) or bilirubin greater than double (2.0 x) the upper limit of normal (ULN)
- •17.Ongoing bacterial or fungal infection requiring antibiotic /-fungal therapy (or completed within 7 days prior to inclusion). Viral infection with Hepatitis B, C and HIV (up to 14 days old negative test results are accepted); or active tuberculosis as indicated by chest X-ray. Every patient will be screened for SARS-CoV2, positive cases will be excluded.
- •18.Active malignant disease or a history of malignancy within two years prior to diagnosis/infusion other than non-melanoma resected or cured skin cancer
- •19.Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study other than those specified.
- •20.Present or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
- •21.Subject who might be dependent on the sponsor, the investigator or the trial site.
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