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Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery (Ten03)

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ClinicalTrials.gov Identifier: NCT01086852
Recruitment Status : Terminated (Closed early due to difficulties in enrolling the target number of 10 surgical procedures.)
First Posted : March 15, 2010
Results First Posted : July 3, 2015
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Factor X Deficiency
Intervention: Biological: FACTOR X

  Participant Flow

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
Active Treatment With FACTOR X Four subjects underwent 4 major surgeries with active treatment (FACTOR X)

Participant Flow:   Overall Study
    Active Treatment With FACTOR X
STARTED   4 
COMPLETED   4 
NOT COMPLETED   0 



  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
Active Treatment With FACTOR X Four patients underwent 4 major surgeries with active treatment (FACTOR X)

Baseline Measures
   Active Treatment With FACTOR X 
Overall Participants Analyzed 
[Units: Participants]
 		 4 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      4 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range) 		 57 
 (55 to 59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      0   0.0% 
Male      4 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      4 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		 
American Indian or Alaska Native      0   0.0% 
Asian      2  50.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      2  50.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 		 
United States   2 
Spain   0 
Turkey   0 
United Kingdom   2 
Germany   0 
India   0 
FX:C at diagnosis (IU/dL) 
[Units: IU/dL]
Median (Full Range) 		 7.5 
 (7 to 8) 


  Outcome Measures

1.  Primary:   Clinical Estimation of Volume of Blood Loss During Surgery   [ Time Frame: Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X. ]
  Show Outcome Measure 1

2.  Primary:   Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder.   [ Time Frame: After wound closure ]
  Show Outcome Measure 2

3.  Primary:   Requirement for Blood Transfusion   [ Time Frame: during and after surgery ]
  Show Outcome Measure 3

4.  Primary:   Number of Post Operative Bleeding Episodes (See Table Below)   [ Time Frame: End of surgery till end of study ]
  Show Outcome Measure 4

5.  Primary:   Change of Haemoglobin From Pre-surgery Till End of Treatment   [ Time Frame: 2 hrs pre-operatively till end of treatment ]
  Show Outcome Measure 5

6.  Primary:   Number of Participants With Degree of Bleeding Control Rated as Excellent.   [ Time Frame: During and till end of treatment ]
  Show Outcome Measure 6

7.  Secondary:   Incremental Recovery After Bolus Dose of FACTOR X   [ Time Frame: incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus ]
  Show Outcome Measure 7

8.  Secondary:   Dose Per Infusion (IU/kg)   [ Time Frame: before surgery, during the post operative period ]
  Show Outcome Measure 8


  Serious Adverse Events


  Other Adverse Events


  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
none reported


  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 less than or equal to 60 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: Miranda Norton
Organization: Bio Products Laboratory
phone: 020 8 957 2661
e-mail: miranda.norton@bpl.co.uk



Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT01086852     History of Changes
Other Study ID Numbers: Ten03
First Submitted: November 10, 2009
First Posted: March 15, 2010
Results First Submitted: January 12, 2015
Results First Posted: July 3, 2015
Last Update Posted: March 10, 2017