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History of Changes for Study: NCT02851407
Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
Latest version (submitted February 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 28, 2016 None (earliest Version on record)
2 September 28, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 November 18, 2016 Study Status and Arms and Interventions
4 January 20, 2017 Study Status and Contacts/Locations
5 March 6, 2017 Study Status and Contacts/Locations
6 March 7, 2017 Study Status
7 March 17, 2017 Contacts/Locations and Study Status
8 April 26, 2017 Contacts/Locations and Study Status
9 June 12, 2017 Study Status and Contacts/Locations
10 August 30, 2017 Contacts/Locations, Eligibility and Study Status
11 September 6, 2017 Arms and Interventions, Study Description and Study Status
12 October 3, 2017 Contacts/Locations and Study Status
13 November 7, 2017 Study Status and Contacts/Locations
14 December 4, 2017 Contacts/Locations and Study Status
15 December 13, 2017 Contacts/Locations and Study Status
16 January 31, 2018 Contacts/Locations and Study Status
17 March 9, 2018 Study Status and Contacts/Locations
18 March 28, 2018 Contacts/Locations and Study Status
19 April 26, 2018 Study Status and Contacts/Locations
20 June 28, 2018 Study Status and Contacts/Locations
21 January 23, 2019 Study Status and Eligibility
22 August 7, 2019 Contacts/Locations and Study Status
23 October 8, 2019 Study Status and Contacts/Locations
24 May 1, 2020 Recruitment Status, Study Status and Contacts/Locations
25 June 15, 2020 Study Status and Contacts/Locations
26 July 2, 2020 Study Status
27 August 4, 2020 Study Status
28 October 21, 2020 Recruitment Status, Study Status, Study Design
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Results Submission Events
29 February 4, 2022 Study Status, Outcome Measures, Document Section, Results, Study Design and Conditions
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Study NCT02851407
Submitted Date:  July 28, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 15-007
Brief Title: 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: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2016
Overall Status: Not yet recruiting
Study Start: September 2016
Primary Completion: January 2021 [Anticipated]
Study Completion: February 2021 [Anticipated]
First Submitted: July 27, 2016
First Submitted that
Met QC Criteria:
July 28, 2016
First Posted: August 1, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 28, 2016
Last Update Posted: August 1, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Jazz Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study is to compare the efficacy and safety of defibrotide versus best supportive care 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:
Open or close this module Conditions
Conditions: Veno-occlusive Disease
Keywords: stem cell transplant
hematopoietic stem cell transplant (HSCT)
veno-occlusive disease (VOD)
sinosoidial obstruction syndrome (SOS)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Defibrotide
Defibrotide solution is administered intravenously at a dose of 25 mg/kg/day
Drug: Defibrotide
Best Supportive Care
Best supportive care according to institutional standards
Best Supportive Care
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 1 Month
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 or autologous 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 of childbearing potential who are sexually active must agree to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the last dose of study drug; male patients with female partners of childbearing potential must agree to use a medically acceptable method of contraception for 6 months after the last dose of study drug.
  4. Patient and/or the 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 has a psychiatric illness that would prevent the patient or 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.
Open or close this module Contacts/Locations
Central Contact Person: Clinical Trial Information Desk
Email: HarmonyTrialInfo@jazzpharma.com
Study Officials: William Tappe, MD
Study Director
Jazz Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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