Efficacy and safety study of defibrotide (DF) for the treatment of venoocclusive disease (VOD).
Phase 2
- Conditions
- Veno Occlusive Disease
- Registration Number
- JPRN-UMIN000013454
- 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
- 20
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.Patient 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 Survival at day 100 post stem cell transplant in patients with VOD after stem cell transplant.
- Secondary Outcome Measures
Name Time Method 1)Efficacy-related outcomes -Survival at day 100, 180 post stem cell transplant and survival time in patients with severe VOD. -Survival at day 100, 180 post stem cell transplant, survival time in patients with VOD at any severity. -Remission of VOD by day 100 after stem cell transplant in patients with severe VOD or VOD of any severity. -Survival at day 100 post stem cell transplant, remission of VOD, and survival time in patients with VOD who started DF within 2 days or on or after 3 days from the onset of VOD. 2)Safety-related outcomes -Bleeding event -Profile of adverse events -Severe adverse events -Discontinuation due to toxicity 3)Phamacokinetic parameters of DF 4)Date of engraftment. 5)Remission status of the original disease before administration and 21 days after starting DF, at day 100 and 180 after stem cell transplant in patients with malignancy.