Veno Occulisive Disease
Conditions
Interventions
defibrotide
Placebo(physical saline)
Sponsors
Fukushima Medical University Clinical Oncology Center, Division of Pediatric Oncology, Atsushi Kikuta
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male Japanese 2. >=20 years old and <=45 years old at voluntary written consent 3. >=50.0 kg and <100.0 kg, and >=18.5 and <25.0 of BMI at screening 4. No history of taken drugs within 6 days at screening 5. Clinical laboratory values are within normal levels in screening and before administration in hospital. 6. Normal in subjective and objective symptoms. 7. Voluntary written consent by themselves is given before screening and is reconfirmed after entering in hospital.
Exclusion criteria
Exclusion criteria: 1. History of abnormal function in CNS, cardiovascular system, respiratory sytem, blood/hematopoietic system, gastroenteric system, liver/kidney, thyroid, pituitary gland, adrenal gland and so on and it is difficult to keep safety of subjects during clinical study. 2. Known hypersensitivity to some drugs 3. Abuse of alcohol or drugs 4. Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection 5. History of blood taken *>=1200ml of all blood within 1 year before screening *>=400ml of all blood with 84 days before screening *>=200ml of all blood within 28 days before screening *taken blood component within 14 days *taken all blood or blood component after screening and before clinical laboratory tests at entering in hospital 6. Treatment with any investigational compound within 120 days before screening or after screening 7. Treatment by other doctors within 28 days before the dose of study drug 8. Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of dose-limiting toxicities of 2 doses of defibrotide | — |
Secondary
| Measure | Time frame |
|---|---|
| Profile of adverse effects of defibrotide Pharmacokinetics of defibrotide Fibrinolytic and coagulation activit | — |
Countries
Japan
Contacts
Public ContactKazuo Umemura
Hamamatsu University Hospital Center for clinical research
Outcome results
None listed