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Clinical trial

IMMUNINE - Purified Factor IX Concentrate Virus-Inactivated: A Phase 4, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B Who Are Planned to Enter BAX 326 Study 250901 to Investigate a New Recombinant FIX Concentrate

NCT01128881 is registered in ClinicalTrials.gov with Baxalta now part of Shire as lead sponsor.

NCT NCT01128881
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Registry record

As filed in ClinicalTrials.gov.

Title
IMMUNINE - Purified Factor IX Concentrate Virus-Inactivated: A Phase 4, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B Who Are Planned to Enter BAX 326 Study 250901 to Investigate a New Recombinant FIX Concentrate
Lead sponsor
Baxalta now part of Shire
Phase
Phase 4
Overall status
Completed
Start date
May 31, 2010
Completion date
August 28, 2012
Enrollment
57 (actual)
Sites
18

Conditions

As the registry lists them; a condition with its own page is linked.

hemophilia b