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Clinical trial

A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

NCT03444324 is registered in ClinicalTrials.gov with Biotest as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)
Lead sponsor
Biotest
Phase
Phase 3
Overall status
Completed
Start date
April 3, 2018
Completion date
November 21, 2023
Enrollment
222 (actual)
Sites
19

Conditions

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

bleeding disorder, hypofibrinogenemia; acquired