Pharmacokinetic study of Treosulfan in patients
- Conditions
- Health Condition 1: null- Hematopoietic stem cell transplantation
- Registration Number
- CTRI/2016/02/006686
- Lead Sponsor
- Emcure Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
The subjects will be selected for study participation, if they meet the following criteria:
1. Class 3 patients with Thalassemia major and patients > 18 years of age with other haematological disorders requiring allogeneic HSCT.
2. Availability of appropriate HLA identical donor
3. Willful written informed consent as per regulatory requirements
4. Performance status 0 â?? 2 (karnofsky performance status >80%)
5. Agreed on adequate contraception in subjects of child bearing age
Subjects will be excluded from the study, if they meet any of the following criteria:
1. Contraindications as per summary of product characteristics
2. H/o of psychiatric illness or malignant involvement of CNS
3. For Class 3 Thalassemia patients - Total Bilirubin 2 x ULN, SGOT & SGPT 5 x ULN is allowed, For other Haematological disorders - Total Bilirubin 2 x ULN, SGOT & SGPT 3 x ULN is allowed.
4. H/o of renal dysfunction (creatinine clearance less than 60ml/min
5. H/o of cardiac and other metabolic disorders
6. H/o respiratory dysfunction
7. HIV positive or active hepatitis or active infectious disease
8. Pregnancy and lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method