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Trial record 13 of 158 for:    bleeding episodes | ( Map: United States )

Clinical Trial of Factor XIII (FXIII) Concentrate

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ClinicalTrials.gov Identifier: NCT00640289
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Children’s Hospital of Orange County

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hemophilia
Factor XIII Deficiency
Intervention Drug: Fibrogammin P
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Factor XIII
Hide Arm/Group Description Prophylactic dose of Factor XIII Concentrate (Human) was to be 10 to 20 U/kg b.w. administered IV over 5 minutes once every 4 weeks, and later tailored to subjects PK profile.
Period Title: Overall Study
Started 72
Completed 59
Not Completed 13
Reason Not Completed
Death             3
Withdrawal by Subject             1
Lost to Follow-up             1
Data collected under different amendment             2
Transferred to another center             1
Missing status             5
Arm/Group Title Factor XIII
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
Safety Population (SP): The safety population consists of all subjects who received a dose of FXIII during the study. Age is age at time of first dose.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants
15.0  (14.09)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
<2 years
9
  12.5%
2 to<16 years
34
  47.2%
16 to<65 years
28
  38.9%
≥65 years
1
   1.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
24
  33.3%
Male
48
  66.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 72 participants
72
 100.0%
1.Primary Outcome
Title Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions
Hide Description Response is defined as: Excellent/Good = adequate hemostasis, similar to that expected for subjects without known bleeding disorders; Fair/Poor = hemostasis less than expected; None = severe bleeding, judged due to disease despite Factor XIII (FXIII) therapy. Only the subjects who needed additional FXIII infusions (apart from the prophylactic treatment) to control a bleed and who had investigator assessment of efficacy were counted in this outcome.
Time Frame Within 12 hours of FXIII infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SP): The safety population consists of all subjects who received a dose of FXIII during the study.
Arm/Group Title Factor XIII
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 22
Overall Number of Units Analyzed
Type of Units Analyzed: Number of bleeds
34
Count of Units
Unit of Measure: Number of bleeds
Excellent/Good
30
  88.2%
Fair/Poor
1
   2.9%
None
0
   0.0%
Missing
3
   8.8%
2.Secondary Outcome
Title Surgical Efficacy Assessments With Factor XIII
Hide Description Surgical efficacy is defined as: Excellent/Good = adequate hemostasis, similar to that expected for subjects without known bleeding disorders; Fair/Poor = hemostasis less than expected; None = severe bleeding, judged due to disease despite Factor XIII (FXIII) therapy. Only the subjects who underwent a surgical procedure were counted in this outcome measure.
Time Frame During surgical procedure
Hide Outcome Measure Data
Hide Analysis Population Description
SP
Arm/Group Title Factor XIII
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Overall Number of Units Analyzed
Type of Units Analyzed: Surgical procedures
16
Count of Units
Unit of Measure: Surgical procedures
Excellent/Good
15
  93.8%
Fair/Poor
0
   0.0%
None
0
   0.0%
Missing
1
   6.3%
Time Frame 9 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Factor XIII
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Factor XIII
Affected / at Risk (%)
Total   3/72 (4.17%)    
Show Serious Adverse Events Hide Serious Adverse Events
Factor XIII
Affected / at Risk (%) # Events
Total   8/72 (11.11%)    
Infections and infestations   
Catheter related infection  1  1/72 (1.39%)  1
Wound infection  1  1/72 (1.39%)  1
Injury, poisoning and procedural complications   
Gunshot wound  1  1/72 (1.39%)  1
Road traffic accident  1  1/72 (1.39%)  1
Nervous system disorders   
Brain mass  1  1/72 (1.39%)  1
Syncope  1  1/72 (1.39%)  1
Psychiatric disorders   
Suicidal behavior  1  1/72 (1.39%)  1
Vascular disorders   
Hypertension  1  1/72 (1.39%)  1
Vasculitis  1  1/72 (1.39%)  1
1
Term from vocabulary, MedDRA version 12.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Factor XIII
Affected / at Risk (%) # Events
Total   32/72 (44.44%)    
Injury, poisoning and procedural complications   
Contusion  1  13/72 (18.06%)  32
Joint injury  1  7/72 (9.72%)  9
Limb injury  1  4/72 (5.56%)  10
Road traffic accident  1  4/72 (5.56%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/72 (8.33%)  22
Skin and subcutaneous tissue disorders   
Rash  1  4/72 (5.56%)  5
1
Term from vocabulary, MedDRA version 12.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Clinical Trial Coordinator
Organization: Children's Hospital of Orange County
Responsible Party: Children’s Hospital of Orange County
ClinicalTrials.gov Identifier: NCT00640289     History of Changes
Other Study ID Numbers: BB-IND5986
First Submitted: March 17, 2008
First Posted: March 21, 2008
Results First Submitted: October 11, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018