Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of H… (NCT02851407) | Clinical Trial Compass
CompletedPhase 3
Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
United States372 participantsStarted 2016-09-01
Plain-language summary
This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.
Who can participate
Age range1 Month
SexALL
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Inclusion criteria
✓. Patient must be above the age of 1 month as of the start date of study treatment.
✓. Patient must be scheduled to undergo allogeneic hematopoietic stem cell transplant (HSCT) (adults or pediatric patients) or autologous HSCT (pediatric patients only) and be at high risk or very high risk of developing veno-occlusive disease (VOD).
✓. Female patients (and female partners of male patients) of childbearing potential who are sexually active must agree to use a highly effective method of contraception with their partners during exposure to defibrotide and for 1 week after the last dose of defibrotide.
✓. Adult patients must be able to understand and sign a written informed consent. For minor patients, the parent/legal guardian or representative must be able to understand and sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion criteria
✕. Patient has hemodynamic instability within 24 hours before the start of study treatment.
✕. Patient has acute bleeding that is clinically significant within 24 hours before the start of study treatment.
✕. Patient used any medication that increases the risk of bleeding within 24 hours before the start of study treatment.
✕. Patient is using or plans to use an investigational agent for the prevention or treatment of VOD.
✕. Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
What they're measuring
1
Veno-occlusive Disease (VOD)-Free Survival by Day +30 Post-Hematopoietic Stem Cell Transplant (HSCT) Per the Independent Endpoint Adjudication Committee (EPAC)
. 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.
✕. 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.
✕. Patient is pregnant or lactating and does not agree to stop breastfeeding.