Original Primary Outcome: Rate (number per subject year) of bleeding episodes requiring treatment with a FXIII containing product during the rFXIII treatment period [ Time Frame: After the last patient has completed the trial period ]

Current Secondary Outcome:

• Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits [ Time Frame: For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). ]
  Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).
• Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits [ Time Frame: For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). ]
  Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).
• Number of Subjects With rFXIII Antibody Development [ Time Frame: For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). ]
  Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)

Original Secondary Outcome:

• Percentage of subjects having a normal clot solubility one hour after rFXIII administration and 28 days after rFXIII administration [ Time Frame: After the last patient has completed the trial period ]
• Level of FXIII activity one hour after rFXIII administration and 28 days after rFXIII administration [ Time Frame: After the last patient has completed the trial period ]
• Number of Subjects With rFXIII Antibody Development [ Time Frame: After the last patient has completed the trial period ]

Dates:
Date Received: July 7, 2008
Date Started: August 2008
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017