EUCTR2012-000658-67-Outside-EU/EEA进行中（未招募）不适用
Multi-centre, oral single dose experimental and modelling study to evaluate the pharmacokinetics of deferiprone in patients aged from 1 month to less than 6 years of age affected by transfusion-dependent haemoglobinopathies - DEEP-1
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)0 个研究点目标入组 30 人开始时间: 2012年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •a) Patients in a chronic transfusional program who have received at
- •least 150 ml/kg/year of packed red blood cells (corresponding
- •approximately to 12 transfusions) and on current treatment with DFO,
- •DFX, DFP; aged from 1 month to less than 6 years.
- •b) Patients naïve to any chelation treatment who have received not less
- •than 150 ml/kg of packed red blood cells (corresponding to
- •approximately 12 transfusions) and have ferritin levels > 800 ng/mL,
- •aged from 1 month to less than 6 years.
- •c) Patients who meet the transfusion criteria (150 ml/kg/year
- •corresponding approximately to 12 transfusions) and have known
- •intolerance or contraindication to DFO
- •And if all of the following criteria apply:
- •d) Patients affected by any hereditary haemoglobinopathies requiring
- •chronic transfusion therapy including but not limited to thalassaemia
- •and sickle cell disease
- •e) Written informed consent obtained from their legal guardian on the
- •patient's behalf in accordance with the national legislations. According to his/her capability, patient's informed assent will be collected
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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
- •a) Patient with known intolerance or contraindication to the trial
- •b) Patient with Hb levels less than 8g/dl (entry may be delayed until
- •values return to normal)
- •c) Patient with platelet count <100.000/mm3 or absolute neutrophil
- •count <1.500/mm3 (entry may be delayed until values return to normal)
- •d) Patient with evidence of abnormal liver function (ALT level >5 times
- •the upper normal limit during six months preceding enrolment; entry
- •may be delayed until values return to normal)
- •e) iron overload from causes other than trasfusional haemosiderosis
- •f) severe heart dysfunction secondary to iron overload defined as the
- •occurrence of heart failure or severe arrhythmia or as indicated by
- •cardiac T2* lower than 10 ms, if recent MRI data is available,
- •g) Patient with serum creatinine level above the upper normal limit at
- •screening; entry may be delayed until values return to normal.
- •h) Serological evidence of chronic hepatitis B (presence of HBe Ag,
- •HBsAg, HBcAb-IgM, in the absence of HBsAb).
- •i) History of significant medical or psychiatric disorder that may impair
- •compliance with the requirements of the protocol.
- •j) The patient has received another investigational drug within 30 days
- •prior to this study.
- •k) Patient with a pre-existing condition or any other surgical or medical
- •condition which might significantly interfere with normal
- •gastrointestinal and hepatic function that could alter the absorption,
- •metabolism, and/or excretion of the study drug.
- •l) Patient with a known history of HIV seropositivity.
- •m) Fever and other signs/symptoms of infection in the 10 days before
- •drug administration(treatment day)
- •n) Concomitant use of other iron chelators or trivalent cation-dependent
- •medicinal products such as aluminium-based antacids.
- •o) Patient with a chronic condition that does not allow suspension of
- •related treatment from starting of washout until drug is administered.
研究者
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