This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors (ProFEIBA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cindy Leissinger MD, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT00221195
First received: September 19, 2005
Last updated: December 12, 2016
Last verified: December 2016
Results First Received: December 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Hemophilia A With Inhibitors
Intervention: Drug: activated prothrombin complex concentrate (FEIBA)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 16 hemophilia treatment centers in Europe and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized to one of two 6 month treatment periods. Following the initial treatment period each subject had a 3 month wash-out period during which time they used on-demand therapy to treat bleeding. Following the 3 month wash-out period each patient was crossed-over to the other 6 month treatment period.

Reporting Groups
  Description
On-demand First Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
Prophylaxis First Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug

Participant Flow:   Overall Study
    On-demand First   Prophylaxis First
STARTED   17   17 
COMPLETED   12   14 
NOT COMPLETED   5   3 
Withdrawal by Subject                4                1 
Death                1                1 
Lost to Follow-up                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
On-demand First Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
Prophylaxis First Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
Total Total of all reporting groups

Baseline Measures
   On-demand First   Prophylaxis First   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   34 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4  23.5%      7  41.2%      11  32.4% 
Between 18 and 65 years      13  76.5%      9  52.9%      22  64.7% 
>=65 years      0   0.0%      1   5.9%      1   2.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.3  (13.4)   24.9  (20.6)   27.1  (17.3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      17 100.0%      17 100.0%      34 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   3   3   6 
Europe   14   14   28 


  Outcome Measures

1.  Primary:   Reduction in the Number of Bleeds   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
One limitation was the relatively short duration; in addition, due to the small number of children enrolled, it is not possible to draw conclusions regarding the relationship of age and the benefits of prophylaxis.


  More Information
  Hide More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cindy Leissinger
Organization: Tulane University
phone: 504-988-5433
e-mail: cleissi@tulane.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cindy Leissinger MD, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT00221195     History of Changes
Other Study ID Numbers: PRO-FEIBA Study
Study First Received: September 19, 2005
Results First Received: December 12, 2016
Last Updated: December 12, 2016