2022-500491-53-00招募中2 期
A Phase IIa, Randomized, Open-label, Proof-of-Concept Study to Evaluate Safety, Tolerability and Efficacy of Ir CPI in Patients with Spontaneous Intracerebral Haemorrhage - the BIRCH study
Bioxodes10 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年2月6日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Adverse event/SAE monitoring
研究概览
简要总结
To assess the safety and tolerability profile of Ir-CPI in ICH patients
研究设计
- 分配方式
- Randomized
- 主要目的
- Cohort 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patients aged ≥ 18 years
- •written informed consent obtained
- •First-ever, spontaneous, supratentorial ICH with a volume ≥ 5 mL but ≤ 60 mL
- •Glasgow Coma Scale (GCS) best motor score no less than 5
- •Modified Rankin Scale (mRS) score 0-2
排除标准
- •History of bleeding disorders
- •Planned anticoagulation reversal treatment
- •Patient with IVH having a Graeb score >3 on initial presentation
- •use of immunosuppressive or immune modulating therapy at admission
- •Patients with active systemic infections
- •Women of childbearing potential
- •body weight > 120 kg
- •severe renal impairement
- •Known deficiency in FXII or haemophilia
- •Infratentorial ICH
- •Secondary ICH
- •Planned neurosurgical hematoma evacuation or other urgent surgical intervention on intial presentation
结局指标
主要结局
Adverse event/SAE monitoring
Adverse event/SAE monitoring
ECGs
ECGs
Vital signs
Vital signs
Physical examinations and neurological evaluations
Physical examinations and neurological evaluations
Biochemistry, haematology
Biochemistry, haematology
coagulation (aPTT)
coagulation (aPTT)
次要结局
- Change from baseline in PHO and haemorrhage volumes measured by CT scan
- Change from baseline in Ir-CPI plasma concentrations
- Change from baseline in aPTT ratio, residual FXI and FXII activities and percentages of inhibition of FXI and FXII procoagulant activities
研究者
Bioxodes SA - info
Scientific
Bioxodes
研究点 (10)
Loading locations...
相似试验
招募中
2 期
Study of the efficacy of treatment with AG-120 in patients with Myelodysplastic Syndrome and mutation IDH12024-515352-20-00Groupe Francophone Des Myelodysplasies48
招募中
3 期
A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with active idiopathic inflammatory myopathy.2022-502851-79-00Argenx80
招募中
1 期
A Study in Adults with Parkinson's Disease and a Lack of Interest or Motivation to Test How Different Doses of IRL757 Given for Multiple Days are Tolerated in the Body2025-523612-37-00Integrative Research Laboratories Sweden AB55
招募中
2 期
Proof of Concept trial with CIT-013 in Rheumatoid Arthritis2024-517356-35-00Citryll B.V.77
招募中
3 期
Hyperthermic Intraperitoneal Chemotherapy in the treatment of Ovarian Cancer relapse2024-517390-24-00Unicancer, Unicancer383