NCT02018393Unknown不适用
Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of plasma levels of anti-FVIII antibodies (neutralising and non-neutralising)
研究概览
简要总结
This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe haemophilia A and inhibitors.
详细描述
This is an observational, multicentric, case-control and one-single-visit study of patients with severe haemophilia A and inhibitors against FVIII in therapy with FEIBA®.
Two subject groups will be included: Group 1 (cases) will be composed of patients with severe haemophilia A and inhibitors in prophylaxis with FEIBA®; Group 2 (controls) will be composed of patients with severe haemophilia A and inhibitors on-demand treatment with FEIBA®.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject has signed and dated the Informed Consent form for participation in this study.
- •Age ≥ 18 years old.
- •Patient with severe haemophilia A (FVIII <1%) and high-responding inhibitor (titre >5 UB) at some point in their life, currently on therapy with FEIBA® to control bleeding.
- •Group 1: Patients in prophylaxis with FEIBA®: The patient has been on prophylaxis regimen with FEIBA® for at least 6 months prior to the study visit. Group 2: Patients on-demand regimen with FEIBA®: The patient has been under on-demand treatment with FEIBA® for at 6 months prior to the study visit.
排除标准
- •The presence of any inflammatory condition at the time of the study visit or the previous 30 days that, according to the medical criterion, would affect the study objectives.
- •The patient is under immune tolerance treatment or has been at any time during the 30 days prior to the study visit.
- •The administration of any anti-inflammatory or immunosuppressive drug 15 days before the study visit.
- •Levels of CD4 <200/l regardless of the HIV status.
- •Altered hepatic or renal function defined by the presence of abnormal levels of alanine aminotransferase (ALAT) or serum creatinine, respectively.
- •Administration of any haemostatic treatment to control bleeding within the 5 days prior to the study visit.
结局指标
主要结局
Measurement of plasma levels of anti-FVIII antibodies (neutralising and non-neutralising)
时间窗: At inclusion
次要结局
- Measurement of the serum levels of inflammatory cytokines(At inclusion)
研究者
Victor Jimenez-Yuste
Medical Degree PhD
Hospital Universitario La Paz
研究点 (1)
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