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Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study (Treatment IND)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00628498
First Posted: March 5, 2008
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jazz Pharmaceuticals
Results First Submitted: November 2, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatic Veno-Occlusive Disease
Intervention: Drug: Defibrotide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Defibrotide Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours

Participant Flow:   Overall Study
    Defibrotide
STARTED   1206 
COMPLETED   1154 
NOT COMPLETED   52 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
Defibrotide Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours

Baseline Measures
   Defibrotide 
Overall Participants Analyzed 
[Units: Participants]
 1154 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 19.32  (20.004) 
[1] Age at time of HSCT/chemo
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      503  43.6% 
Male      651  56.4% 


  Outcome Measures

1.  Primary:   Survival by Day+100 Post Stem Cell Transplant or Chemotherapy   [ Time Frame: Day +100 from HSCT or 100 days from start of chemotherapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Trial Disclosure & Transparency
Organization: Jazz Pharmaceuticals
phone: (215) 832-3750


Publications of Results:

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00628498     History of Changes
Other Study ID Numbers: P2006-05
First Submitted: February 25, 2008
First Posted: March 5, 2008
Results First Submitted: November 2, 2017
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017