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Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment (SPINART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00623480
First received: February 4, 2008
Last updated: November 5, 2014
Last verified: November 2014
Results First Received: May 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hemophilia A
Intervention: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

  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
Recombinant Factor VIII Prophylaxis Treatment Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Recombinant Factor VIII On-demand Treatment Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.

Participant Flow:   Overall Study
    Recombinant Factor VIII Prophylaxis Treatment     Recombinant Factor VIII On-demand Treatment  
STARTED     42     42  
COMPLETED     35     35  
NOT COMPLETED     7     7  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 2                 4  
Lack of Efficacy                 1                 0  
Non-compliant with study medication                 4                 0  
Protocol Violation                 0                 1  
Site closed by sponsor                 0                 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.
No text entered.

Reporting Groups
  Description
Recombinant Factor VIII Prophylaxis Treatment Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Recombinant Factor VIII On-demand Treatment Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
Total Total of all reporting groups

Baseline Measures
    Recombinant Factor VIII Prophylaxis Treatment     Recombinant Factor VIII On-demand Treatment     Total  
Number of Participants  
[units: participants]
  42     42     84  
Age  
[units: Years]
Mean ± Standard Deviation
  30.6  ± 8.8     30.7  ± 9.7     30.6  ± 9.2  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     42     42     84  
Number of bleeds during last 6 months  
[units: Bleeds]
Mean ± Standard Deviation
  10.0  ± 4.4     12.2  ± 5.1     11.1  ± 4.8  
Number of patients with target joints, Yes/No [1]
[units: Participants]
     
Yes     28     31     59  
No     14     11     25  
[1] A ‘target joint’ is a particular joint that has experienced repeated bleeds or at least four bleeds into one joint within a six month period.



  Outcome Measures
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1.  Primary:   Bleeding Frequency (Number of Total Bleeds)   [ Time Frame: After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days) ]

2.  Secondary:   Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.   [ Time Frame: Baseline and 3 years ]

3.  Secondary:   Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale   [ Time Frame: Baseline and 3 years ]

4.  Other Pre-specified:   Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A   [ Time Frame: Baseline and 3 years ]


  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: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00623480     History of Changes
Other Study ID Numbers: 12800, 2008-000985-21
Study First Received: February 4, 2008
Results First Received: May 2, 2013
Last Updated: November 5, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Argentinia: National Administration of Drug, Food and Medical Technology
Romania: National Medicines Agency