Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

Exclusion Criteria

• •1. Patient has hemodynamic instability within 24 hours before the start of study treatment.
• •2. Patient has acute bleeding that is clinically significant within 24 hours before the start of study treatment.
• •3. Patient used any medication that increases the risk of bleeding within 24 hours before the start of study treatment.
• •4. Patient is using or plans to use an investigational agent for the prevention or treatment of VOD.
• •5. Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
• •6. Patient or parent/legal guardian or representative has a psychiatric illness that would prevent the patient or parent/legal guardian or representative from giving informed consent and/or assent.
• •7. Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.
• •8. Patient is pregnant or lactating and does not agree to stop breastfeeding.
• •9. Patient has a known history of hypersensitivity to defibrotide or any of the excipients.
• •10. Patient or parent/legal guardian or representative lacks the full mental capacity to understand and sign a written informed consent.
• •11. Patient is receiving or plans to receive other investigational therapy during study.