Trial record 3 of 8 for:    beriplex p/n

An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure (BE1116_3003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00803101
First received: December 4, 2008
Last updated: March 11, 2014
Last verified: March 2014
Results First Received: January 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Reversal of Coagulopathy
Interventions: Biological: Beriplex® P/N (Kcentra)
Biological: Fresh frozen plasma

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Beriplex® P/N Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (INR), amount of coagulation factor IX and body-weight.
Fresh Frozen Plasma Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight

Participant Flow:   Overall Study
    Beriplex® P/N     Fresh Frozen Plasma  
STARTED     88     88  
COMPLETED     70     66  
NOT COMPLETED     18     22  
Death / Serious Adverse Event                 4                 6  
Withdrawal by Subject                 6                 4  
Lost to Follow-up                 2                 2  
Protocol Violation                 1                 7  
Surgery finished outside protocol window                 1                 1  
Patient died outside SAE report period                 1                 0  
Patient did not attend scheduled visit                 2                 1  
Patient did not have surgery                 1                 1  



  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.
The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.

Reporting Groups
  Description
Beriplex® P/N Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
Fresh Frozen Plasma Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
Total Total of all reporting groups

Baseline Measures
    Beriplex® P/N     Fresh Frozen Plasma     Total  
Number of Participants  
[units: participants]
  87     81     168  
Age, Customized  
[units: participants]
     
< 65 years     32     39     71  
>= 65 to < 75 years     21     19     40  
>= 75 years     34     23     57  
Gender  
[units: participants]
     
Female     37     31     68  
Male     50     50     100  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Hemostatic Efficacy During Surgery   [ Time Frame: From the start of infusion until the end of surgery ]

2.  Primary:   Percentage of Participants Who Had a Rapid Decrease of the INR   [ Time Frame: 30 minutes after the end of infusion ]

3.  Secondary:   Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S   [ Time Frame: From pre-infusion until 24 h after the start of infusion ]

4.  Secondary:   Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood   [ Time Frame: From the start of surgery until 24 h after the start of surgery ]

5.  Secondary:   Percentage of Participants With INR Correction at Various Times After the Start of Infusion   [ Time Frame: From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion ]

6.  Secondary:   Percentage of Participants Who Received Red Blood Cells   [ Time Frame: From the start of surgery until 24 h after the start of surgery ]

7.  Secondary:   Overall Treatment-emergent Adverse Events (TEAEs)   [ Time Frame: From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
phone: Use email contact
e-mail: clinicaltrials@cslbehring.com


No publications provided


Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00803101     History of Changes
Other Study ID Numbers: BE1116_3003, 1474, 2007-007862-39
Study First Received: December 4, 2008
Results First Received: January 12, 2014
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Armenia: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Belarus: Ministry of Health
Romania: National Medicines Agency