Efficacy and safety study of defibrotide (DF) for the prophylaxis of venoocclusive disease (VOD).
Not Applicable
- Conditions
- Veno Occlusive Disease
- Registration Number
- JPRN-UMIN000013455
- Lead Sponsor
- Fukushima Medical University Hospital Atsushi Kikuta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Not provided
Exclusion Criteria
1.Using medication that increases risk of hemorrhage. 2.Acute bleeding that is not controlled. 3.Unstable hemodynamic status that require more than one vasopressor or decreased mean atrial pressure (MAP). 4.Complicated with viral fulminant hepatitis 5.Past history of organ transplant other than hematopoietic cell transplant. 6.Complicated with Grade IV GVHD 7.Females with pregnancy, breastfeeding, possible pregnancy. Male who will not consent contraception 8.Judged as inappropriate for participating in the study by the principal or other investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of VOD until day 30 post stem cell transplant in patients who undergo prophylaxis with DF. Principal or other investigator should evaluate the development of VOD according to the revised Seattle criteria. VOD is defined as those who meet at least 2 of the following criteria by day 35 post stem cell transplant. -T-Bil>=2mg/dL -Hepatomegaly -Right hypochondriac pain -Ascites -Unexplained weight gain of>5% from baseline.
- Secondary Outcome Measures
Name Time Method To compare the following outcomes both in DF prophylaxis group and control (no prophylaxis) group. 1)Incidence of VOD at day 30, 100 post stem cell transplant. 2)Incidence of VOD according to the Baltimore criteria at day 30, 100 post stem cell transplant. 3)Severity of VOD in patients who developed VOD. 4)Incidence of total, grade II-IV, and III-IV acute GVHD at day 100 post stem cell transplant. 5)Survival at day 100, 180 post stem cell transplant. 6)Survival at day 100, 180 post stem cell transplant in patients who developed VOD. 7)Incidence and severity of adverse events and drug-related adverse event. 8)Date of engraftment. 9)Remission status of the original disease at day 30, 100, and 180 after stem cell transplant in patients with malignancy.