EUCTR2009-010147-14-GB进行中（未招募）不适用
A diagnostic interventional, controlled, cross-sectional evaluation of joint status using MRI in subjects with severe hemophilia A treated with primary prophylaxis, secondary prophylaxis, or on-demand therapy - MRI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- Male
入选标准
- •Test subjects (for MRI quality assessment)
- •-----------------------------------------------------
- •Males aged 18 - 35 years
- •Severe hemophilia A (< 1% FVIII:C)
- •Written informed consent by subject
- •Investigation subjects only (subjects participating in the full investigation)
- •---------------------------------------------------------------------------------------------
- •Males aged 12 - 35 years
- •Severe hemophilia A ( < 1 % FVIII:C)
- •No history of Factor VIII inhibitory antibody measured using the Bethesda assay
- •(< 0.6 BU/ml)
- •For prophylaxis groups, having received at least two prophylactic infusions per
- •week for 45 weeks per year for the prevention of bleeding without relevant
- •interruption for a consecutive period beginning at prophylaxis initiation and
- •continuing until the present. Relevant interruption is defined as having received
- •therapy that does not qualify as prophylaxis by the above definition or missing
- •documentation of bleeds and consumption for more than 12 consecutive months.
- •Complete documentation of joints bleeds and their locations prior to start of
- •primary prophylaxis, documentation of the joint status or the joint bleeds and their
- •location of the previous 6 months before start in case of secondary prophylaxis.
- •Bleeding history and/or treatments received during the last 5 years documented in
- •the subjects’ medical records. The minimum data required is the number and
- •location of joint bleeds, treatment schedule, and Factor VIII consumption over the
- •last 5 years.
- •For the on-demand subjects > 12 bleeds/year in the last 5 years.
- •Written informed consent by subject and parent/legal representative, if < 18 years
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Test subjects (for MRI quality assessment)
- •-----------------------------------------------------
- •Individuals for whom high-magnetic exposure is contraindicated
- •Individuals who, in the opinion of the physician, would not be able to meet the
- •requirements of the MRI technique
- •Investigation subjects only (subjects participating in the full investigation)
- •---------------------------------------------------------------------------------------------
- •Individuals with other coagulopathies (e.g., von Willebrand disease)
- •HIV seropositive subjects
- •Individuals for whom the most clinically severe joint is not one of the 4 index joints
- •(ankle, knee)
- •HCV seropositive individuals who underwent interferon therapy during the last 12
- •Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)
- •Individuals who, in the opinion of the physician or parent/guardian, would not be
- •able to meet the requirements of the MRI technique
- •Synovectomy performed within the six months prior to investigation enrollment or
- •orthopedic surgery planned to be performed within the investigation period
- •Joint replacement
- •For the on-demand treatment group, any period greater than 8 consecutive
- •months having received = 50 IU per kg per week Factor VIII for the prevention of
研究者
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