Patients with various hematological disease requiring Bone Marrow Transplantation, with Child-Pugh score A and B MedDRA version: 17.0 Level: LLT Classification code 10067859 Term: Allogenic stem cell transplantation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Tepadina
Product Name: Thiotepa
Pharmaceutical Form: Powder for infusion
Sponsors
ADIENNE SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the effect of moderate hepatic impairment on the pharmacokinetics of Thiotepa and its metabolite triethylenephosphoramide (TEPA) in pediatric patients undergoing allogeneic bone marrow transplantation. The pK parameters of Thiotepa and TEPA will be compared in two paediatric populations characterized by different levels of liver function as defined by Child-Pugh Score A vs score B. ;Secondary Objective: The secondary objective is to assess the cardiac safety of Thiotepa, in particular in relation to the ventricular repolarization (QT/QTc interval analysis), in pediatric patients.;Primary end point(s): - Apparent total plasma clearance (CL/F) - Area Under the concentration Curve (AUC);Timepoint(s) of evaluation of this end point: Assessed during the 2 administrations of Thiotepa on sane day (blood drawings at 8 time points) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ECG analysis of ventricular repolarisation (QT/QTc interval); - Incidence of Treatment Emergent Adverse Events (TEAEs).;Timepoint(s) of evaluation of this end point: During and 24 hours after Thiotepa administration (also 7 days post administration on case of ECG alterations) | — |
Countries
Italy
Contacts
Public ContactStudy Coordinator
ADIENNE SA
Outcome results
None listed