EUCTR2004-000592-33-SE进行中（未招募）不适用
Prospective Study of the Incidence and Outcome of Venoocclusive Disease (VOD) with the Prophylactic Use of Defibrotide (DF, Gentium, Italy) in Pediatric Stem Cell Transplantation - VOD-DF Study
Gentium S.p.A0 个研究点目标入组 270 人开始时间: 2006年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients < 18 years who have myeloablative conditioning and at least one of the following risk factors:
- •Children having a second myeloablative stem cell transplant
- •Allogeneic stem cell transplants for leukaemia >2 relapses
- •Liver disease
- •History of treatment with gemtuzumab ozogamicin (Mylotarg)
- •Conditioning with busulfan and melphalan
- •Osteopetrosis
- •Macrophage activating syndromes
- •Adrenoleukodystrophy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Those who do not fulfill the inclusion criteria.
- •Patients who are pregnant.
研究者
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Prospective Study of the Incidence and Outcome of Venoocclusive Disease (VOD) with the Prophylactic Use of Defibrotide (DF, Gentium, Italy) in Pediatric Stem Cell Transplantation - VOD-DF StudyHepatic veno-occlusive disease following hematopoietic stem cell transplantationEUCTR2004-000592-33-IEGentium S.p.A290
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Prospective study of the incidence and outcome of Veno-occlusive disease (VOD)with the prophylactic use of Defibrotide (DF, Gentium, Italy) in pediatric stem cell transplantatioPrevention of hepatic veno-occlusive disease in pediatric patients at high risk of VODMedDRA version: 14.1Level: PTClassification code 10047216Term: Venoocclusive liver diseaseSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2004-000592-33-ITGENTIUM360
尚未招募
Unknown
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