Phase IV study to assess, the effect of hepatic impairment on the pharmacokinetics of Thiotepa and the potential of Thiotepa to alter the QT interval in pedatric patients undergoing allogeneic haematopoietic progenitor cell transplantation. - Not applicable

ADIENNE SA0 个研究点开始时间: 2014年10月23日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•1)Parents’/guardian’s written informed consent and patient’s assent (written, if applicable) before beginning any investigational procedures;
•2)Male/ female subjects aged >1 and < 18 years;
•3)Diagnosis of any haematological disease requiring allogeneic HPCT;
•4)Eligible to allogeneic HPCT;
•5)Subjects with no hepatic function impairment (Child-Pugh, score A) or with mild-moderate hepatic function impairment (Child-Pugh, score B);
•6)Lansky or Karnofsky Index = 60.
•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

•1)Patients who already underwent HPCT;
•2)Child-Pugh score C;
•3)Patients with clinically significant EGC abnormalities;
•4)Hepatitis B or C;
•5)HIV-positivity;
•6)Any malignancy different from the one for which the HPCT is scheduled;
•7)Severe neurological impairment;
•8)Severe psychiatric disorders;
•9)Clinically significant pleural effusion or ascites;
•10)Severe organ impairment, as shown by:
•a.LVEF < 40%, or
•b.FEV1, FVC, DLCO <50% of predicted, or
•c.Advanced liver cirrhosis, or
•d.Liver function tests (bilirubin, AST/ALT transaminases, Alkaline Phosphatase) > 10 x upper limit of normal (ULN), or
•e.Creatinine clearance < 40 ml/min;
•11)Patients having received in the 10 days preceding the administration of Thiotepa, or requiring in concomitance with Thiotepa:
•a.CYP2B6 inhibitors (e.g. clopidogrel, ticlopidine), or
•b.CYP3A4 inhibitors (e.g. azole antimycotics, macrolides as erythromycin, clarithromycin, telitromycin and protease inhibitors), or
•c.Cytocrome P450 inducers (as rifampicin, carbamazepin, phenobarbital).
•12)Pregnancy or lactation;
•13)Known hypersensitivity to trial drugs;
•14)Non-cooperative behaviour of the patient or non-compliance.
•15)Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.

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