Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00916032
First received: June 5, 2009
Last updated: September 3, 2013
Last verified: September 2013
Results First Received: March 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hemophilia A
Intervention: Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]

  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 in Russia and Bulgaria at 4 clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
29 participants were enrolled. Six participants discontinued, (four were screen failures and two were withdrawn before randomization). Therefore 23 participants were randomized.

Reporting Groups
  Description
Two 1500 IU Vials Then One 3000 IU Vial Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by one 3000 IU potency vial dissolved in 5 mL diluent.
One 3000 IU Vial Then Two 1500 IU Vials Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)

Participant Flow:   Overall Study
    Two 1500 IU Vials Then One 3000 IU Vial     One 3000 IU Vial Then Two 1500 IU Vials  
STARTED     12     11  
COMPLETED     12     11  
NOT COMPLETED     0     0  



  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
All Study Participants Participants were randomized to receive via intravenous infusion 3000 International Units (IU) Advate using either one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Mean ± Standard Deviation
  36.5  ± 13.2  
Gender  
[units: participants]
 
Female     0  
Male     23  
Region of Enrollment  
[units: participants]
 
Bulgaria     14  
Russian Federation     9  



  Outcome Measures
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1.  Primary:   Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

2.  Primary:   Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

3.  Secondary:   Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

4.  Secondary:   Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

5.  Secondary:   Incremental Recovery at Cmax - Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours. ]

6.  Secondary:   Incremental Recovery at Cmax - One-stage aPTT Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours. ]

7.  Secondary:   Incremental Recovery at 30 Minutes- Chromogenic Assay   [ Time Frame: 30 minutes pre-infusion and 30 minutes post-infusion ]

8.  Secondary:   Incremental Recovery at 30 Minutes- One-stage aPTT Assay   [ Time Frame: 30 minutes pre-infusion and 30 minutes post-infusion ]

9.  Secondary:   Elimination Phase Half-life- Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

10.  Secondary:   Elimination Phase Half-life- One-stage aPTT Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

11.  Secondary:   FVIII Clearance- Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

12.  Secondary:   FVIII Clearance- One-stage aPTT Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

13.  Secondary:   Mean Residence Time (MRT)- Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

14.  Secondary:   Mean Residence Time (MRT)- One-stage aPTT Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

15.  Secondary:   Volume of Distribution at Steady State- Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

16.  Secondary:   Volume of Distribution at Steady State- One-stage aPTT Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

17.  Secondary:   Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]

18.  Secondary:   Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay   [ Time Frame: Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours. ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Brigitt Abbuehl, MD, Medical Director, Hematology/Hemophilia
Organization: Baxter
e-mail: brigitt_abbuehl@baxter.com


No publications provided


Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00916032     History of Changes
Other Study ID Numbers: 060801
Study First Received: June 5, 2009
Results First Received: March 31, 2013
Last Updated: September 3, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
Russia: Ministry of Health of the Russian Federation