EUCTR2012-002920-33-GB进行中（未招募）1 期
A Randomized Controlled Study to Evaluate Efficacy and Safety of INTERCEPT Treated Red Blood Cells (RBC) in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion - Clinical study to evaluate INTERCEPT RBC in Thalassemia patients v5.0
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
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
- •Age =11 years, of either gender.
- •Female subjects will be either: Non-childbearing potential or Childbearing potential. Women of childbearing potential must have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy. Females of childbearing potential must be willing to consent to using methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomized partner
- •Diagnosed with thalassemia major and currently participating in a chronic transfusion program
- •At least a one year history of chronic RBC transfusion support with a stable transfusion requirement (per treating physician)
- •Intervals of at least 14 days between RBC transfusions
- •All RBC components are given on one day for each transfusion episode
- •Signed and dated informed consent form
- •Pediatric assent is granted (when required by local regulations)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Baseline serum/plasma sample with antibody specific to INTERCEPT treated RBCs (positive RBC screening test)
- •Evidence of splenic hyperfunction defined as a transfusion requirement >180 mL/kg/year (at 100% hematocrit)
- •Splenic enlargement: spleen palpable =4 cm below costal margin OR =18 cm in longitudinal diameter by ultrasound (chosen at the Investigator’s discretion according to the data available with ultrasound data being preferable)
- •Any subject for whom a substantial change in the number of RBC components transfused is anticipated within 12 months of study entry due to anticipated splenectomy or other change in clinical status
- •Subjects at high risk of cardiac decompensation (e.g., subjects with a documented left ventricle ejection fraction <56%, or with a multislice multiecho T2* cardiac magnetic resonance <10 ms)
- •Alloimmunization to high frequency blood group antigens to the extent that the provision of compatible blood may not be feasible for the study (alloimmunization alone is not an automatic exclusion)
- •Current specialized treatment with washed or frozen RBC
- •Requirement for gamma irradiated RBC components (would present blinding difficulty due to blood component labeling regulations)
- •Subject with G-6PD deficiency requiring treatment with medications that are known to adversely affect RBC viability (see Appendix D)
- •Positive DAT based on the defined algorithm for evaluation as defined below (and presented in Section 7.3.1.):
- •oA poly-DAT reaction strength >2+
- •oPan-reactivity of subject plasma/serum sample with a CE marked commercial IAT antibody screening panel (e.g., ID-DiaCell panel, with or without papain) that precludes the identification of underlying allo-antibodies or indicates the presence of auto-antibody
- •Documented active HIV infection (defined as RNA positive)
- •Documented active HCV infection (defined as RNA positive) and currently treated with concomitant medications known to suppress the bone marrow function
- •Pregnant or breast feeding females
- •Currently receiving chemotherapy for treatment of cancer
- •Acute or chronic medical disorder other than thalassemia that, in the opinion of the investigator or medical monitor, may prevent the subject from completing participation in the study
- •If in the Investigator’s opinion the subject cannot comply with the protocol, they may be deemed ineligible
- •Participation in another clinical study, either concurrently or within the previous 28 days
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