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Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery

This study has been completed.
Sponsor:
Collaborator:
Baxalta Innovations GmbH, now part of Shire
Information provided by (Responsible Party):
Baxalta US Inc.
ClinicalTrials.gov Identifier:
NCT00357656
First received: July 25, 2006
Last updated: April 12, 2017
Last verified: January 2017
Results First Received: January 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hemophilia A
Intervention: Drug: Recombinant Protein-Free Factor VIII (rAHF-PFM)

  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
Enrollment was conducted at 22 clinical sites in 12 countries (US, Austria, Norway, France, Portugal, Netherlands, Spain, Russia, Romania, Hungary, Italy, Poland). Of 85 participants enrolled, 72 participants participated in a PK study in the preoperative period; 63 participants were then randomized to treatment by continuous or bolus infusion.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 85 participants enrolled,15 were screen failures (2 after PK), 4 discontinued on the basis of the PK study in the preoperative period, 1 died, 1 was discontinued by physician decision (imprisonment), and 1 was discontinued per sponsor decision. Eventually, 63 participants were randomized to treatment by continuous (n=32) or bolus infusion (n=31)

Reporting Groups
  Description
Bolus Infusion Bolus infusion of ADVATE (rAHF-PFM)
Continuous Infusion Continuous infusion of ADVATE (rAHF-PFM)

Participant Flow:   Overall Study
    Bolus Infusion   Continuous Infusion
STARTED   31   32 
COMPLETED   31   29 
NOT COMPLETED   0   3 
Other, No surgery performed                0                3 



  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.
No text entered.

Reporting Groups
  Description
Bolus Infusion Bolus infusion of ADVATE (rAHF-PFM)
Continuous Infusion Continuous infusion of ADVATE (rAHF-PFM)
Total Total of all reporting groups

Baseline Measures
   Bolus Infusion   Continuous Infusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   32   63 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31 100.0%      32 100.0%      63 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.6  (9.76)   39.0  (11.52)   38.8  (10.61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      31 100.0%      32 100.0%      63 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cumulative Packed Red Blood Cell (PRBC) Volume in the Drainage Fluid During the First 24 Hours Following Surgery in Subjects Receiving ADVATE (rAHF-PFM) by Bolus (BI) or Continuous Infusion (CI)   [ Time Frame: During the first postoperative 24 hours every 8 hours ± 30 minutes the drainage fluid was to be recorded.. ]

2.  Secondary:   Actual Postoperative Blood Loss During the First 24 Hours Compared With the Average Blood Loss as Predicted Preoperatively by the Operating Surgeon   [ Time Frame: During the first 24 postoperative hours blood loss was measured every 8 hours ± 30 minutes ]

3.  Secondary:   Actual Postoperative Blood Loss Compared to the Expected Average Blood Loss Until Drain Removal as Predicted Preoperatively by the Surgeon   [ Time Frame: From end of surgery (application of compressive dressing and release of tourniquet, if applicable) until drain removal (up to postoperative day 7). ]

4.  Secondary:   Number of Bleeding Episodes During Treatment With Continuous or Bolus Infusion   [ Time Frame: Through Postoperative Day 7 ]

5.  Secondary:   Number of Units of Packed Red Blood Cells Transfused   [ Time Frame: During the first postoperative 24 hours ]

6.  Secondary:   Number of Adverse Events Related to the Administration of the Study Product.   [ Time Frame: From first study drug exposure until study completion/discontinuation (approximately 9-26 weeks per subject) ]

7.  Secondary:   Incidence of Factor VIII Inhibitory Antibody (≥0.4 Bethesda Units Using the Nijmegen Modification of the Bethesda Assay Formation)   [ Time Frame: Throughout the study period of approximately 9-26 weeks per participant ]


  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 Registries and Results Disclosure
Organization: Baxalta US Inc
e-mail: ClinicalTrialsDisclosure@baxalta.com



Responsible Party: Baxalta US Inc.
ClinicalTrials.gov Identifier: NCT00357656     History of Changes
Other Study ID Numbers: 060402
Study First Received: July 25, 2006
Results First Received: January 11, 2017
Last Updated: April 12, 2017