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Trial record 1 of 3 for:    JZP-381 | Germany
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Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

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ClinicalTrials.gov Identifier: NCT02851407
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 27, 2016
First Posted Date  ICMJE August 1, 2016
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Veno-Occlusive Disease (VOD)-Free Survival at Day 30 Post-Hemotopoietic Stem Cell Transplant (HSCT) [ Time Frame: 30 Days Post-Transplant ]
Comparison of efficacy of defibrotide vs Best Supportive Care (BSC) for the prevention of VOD
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Veno-Occlusive Disease (VOD)-Free Survival at Day 100 Post-Hemotopoietic Stem Cell Transplant (HSCT) [ Time Frame: 100 Days Post-Transplant ]
Comparison of efficacy of defibrotide vs Best Supportive Care (BSC) for the prevention of VOD
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
Official Title  ICMJE A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Veno-occlusive Disease
Intervention  ICMJE
  • Drug: Defibrotide
  • Other: Best Supportive Care
Study Arms  ICMJE
  • Experimental: Defibrotide
    Defibrotide is administered intravenously at a dose of 25 mg/kg/day in addition to best supportive care on the day before the first day of the conditioning regimen and will continue (for those patients without a VOD diagnosis) for a recommended minimum of 21 days and end no later than Day +30 post HSCT
    Intervention: Drug: Defibrotide
  • Best Supportive Care
    Best supportive care alone (without the addition of defibrotide) according to institutional guidelines and patient need, is administered on the first day of conditioning and will continue until Day +30 post HSCT or hospital discharge, whichever is sooner, or diagnosis of VOD, if applicable
    Intervention: Other: Best Supportive Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2020)
373
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
400
Actual Study Completion Date  ICMJE October 13, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient must be above the age of 1 month as of the start date of study treatment.
  2. 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).
  3. 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.
  4. 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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Australia,   Belgium,   Canada,   France,   Israel,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02851407
Other Study ID Numbers  ICMJE 15-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jazz Pharmaceuticals
Study Sponsor  ICMJE Jazz Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jazz Pharmaceuticals Jazz Pharmaceuticals
PRS Account Jazz Pharmaceuticals
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP