A phase II, multicentre, clinical study evaluating the safety and efficacy of Treosulfan-based conditioning of allogenic transplantation of haemopoietic stem-cells in patients affected by Thalassemia Major - ND
- Conditions
- Thalassemia MajorMedDRA version: 6.1Level: SOCClassification code 10005329
- Registration Number
- EUCTR2005-005913-40-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- patients affected by Thalassemia Major - age 1-30 years old, etc...
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Exclusion Criteria
- not provided written voluntary informed consent by parents -hepatic desease, etc...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: to evaluate overall survival OS , etc...;Primary end point(s): to evaluate rapid engraftment, etc...;Main Objective: to evaluate the safety and efficacy of Treosulfan-based conditioning of allogenic transplantation of haemopoietic stem-cells in patients affected by Thalassemia Major
- Secondary Outcome Measures
Name Time Method