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Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01434511
First Posted: September 15, 2011
Last Update Posted: July 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
Results First Submitted: December 11, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hemophilia A
Intervention: Biological: OBI-1

  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
OBI-1 OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment

Participant Flow:   Overall Study
    OBI-1
STARTED   1 
COMPLETED   1 
NOT COMPLETED   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.
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).

Reporting Groups
  Description
OBI-1 OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment

Baseline Measures
   OBI-1 
Overall Participants Analyzed 
[Units: Participants]
 0 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
  
[1] This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Gender [1] 
[Units: Participants]
  
[1] This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Region of Enrollment [1] 
[Units: Participants]
  
[1] This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Serious Bleeding Episodes Responsive to OBI-1   [ Time Frame: 24 hours after initiation of treatment ]

2.  Secondary:   Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

3.  Secondary:   Proportion of Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

4.  Secondary:   Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

5.  Secondary:   Total Dose of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

6.  Secondary:   Total Number of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

7.  Secondary:   Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

8.  Secondary:   Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode.   [ Time Frame: Frame: Through 90 days ± 7days following final OBI-1 dose ]

9.  Secondary:   Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers and the Recovery of OBI-1.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

10.  Secondary:   Recovery and Elimination Rate Parameters of OBI-1 in Subjects With Inhibitors Treated With OBI-1 Therapy.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

11.  Secondary:   Efficacy Assessment of OBI-1 in Participants With Anti-human Factor VIII Titers >30 Bethesda Units (BU)   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

12.  Secondary:   Anti-human Factor VIII Antibody Titer.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

13.  Secondary:   Anti-OBI-1 Antibody Titer.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]

14.  Secondary:   Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer.   [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]


  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
No text entered.


  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: Heinrich Farin, MD
Organization: Baxter Healthcare Corporation
e-mail: heinrich_farin@baxter.com



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01434511     History of Changes
Other Study ID Numbers: OBI-1-302
First Submitted: September 13, 2011
First Posted: September 15, 2011
Results First Submitted: December 11, 2014
Results First Posted: December 17, 2014
Last Update Posted: July 21, 2015