NL-OMON45838招募中2 期
Treatment of congenital vascular malformations using Sirolimus: improving quality of Life - Treatment of congenital vascular malformations with Sirolimus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
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
- 年龄范围
- 2 至 64（—）
入选标准
- •Diagnosis of Congenital venous malformation, or lymphatic malformation or combined.
- •Age between 1-70 years.
- •Patients (or legal guardians for children) have to be able to sign the informed consent
- •Patients are either refractory to standard care such as medical treatment (low molecular weight heparines, pain medication etc.), surgical resection and/or sclerotherapy/embolization (ineffective or accompanied by major complications) or there is no possibility for surgical intervention anymore. Only patients that have a normal clinical screening (no signs for infection, normal bone marrow function, normal liver and kidney function, normal glucose metabolism etc.) can be included.
- •Patients included have no cardiac impairment
- •Patients have no gastrointestinal impairment as Sirolimus is absorbed gastro-intestinal and normal function is needed
- •No other underlying medical disorder like Down syndrome or other syndromes
- •Women of reproductive age have to be informed that contraceptive methods are
- •mandatory during the study time, pregnant women are excluded as also breast-feeding women
- •Karnofsky score > 50
排除标准
- •No written informed consent
- •Known hypersensitivity to drugs or metabolites from similar classes as study
- •Patient has other concurrent severe and /or uncontrolled medical condition that would, in the investigator*s judgment, contraindicated participation in the clinical study (e.g. acute or chronic pancreatitis, liver cirrhosis, active chronic hepatitis, severely impaired lung function with a spirometry <= 50% of the normal predicted value and/or O2 saturation <= 88% at rest, etc.)
- •Recent history of primary malignancy <= 5 years
- •Impaired cardiac function or clinically significant cardiac diseases
- •Immunocompromised patients, including known seropositivity for HIV
- •Patient with any other concurrent severe and /or uncontrolled medical condition that
- •would,in the investigator*s judgment, contraindicated participation in the clinical
- •Pregnant or lactating women
- •Karnofsky score < 50
研究者
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