A Phase 3 interventional study of Fibrinogen Concentrate, Human (FCH) and Cryoprecipitate in Afibrinogenemia, Hypofibrinogenemia and Fibrinogen Deficiency, sponsored by CSL Behring. Withdrawn. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by CSL Behring (part of CSL Limited) · Phase 3, Interventional, and Treatment
This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).
It is estimated that 150-300 patients in the U.S. suffer from afibrinogenemia. Substitution with cryoprecipitate or alternative treatments have limited safety and efficacy.
The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma) in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used as a historical control.
CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after CSL Behring became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Biological: Fibrinogen Concentrate, Human (FCH)
Biological: Cryoprecipitate
Intravenous (IV) infusion to reach the peak target levels of 100 mg/dL with an accepted lower limit of 80 mg/dL on at least 3 subsequent days for minor bleeding episodes and 150 mg/dL with an accepted lower limit of 130 mg/dL on at least 7 subsequent days for major bleeding episodes. If a subject's fibrinogen level is not known on Day 1, at the time treatment is initiated for the acute bleed (e.g., because they did not have a screening visit), the starting dose is to be 70 mg/kg b.w. Otherwise, the dose will be calculated individually.
Also known as: Haemocomplettan P, RIASTAP
Patients that received on-demand treatment with Cryoprecipitate for a classified bleeding event (minor or major) with a documented hemostatic efficacy assessment.
Clinical assessment of hemostatic efficacy
Time frame: 24 hours after last infusion or at Day 14 (whichever occurs first)
Maximum clot firmness (MCF)
Time frame: Prior to and 60 minutes after the end of each infusion
Fibrinogen plasma level
Time frame: 60 minutes, 3 hours, 6 hours, and 12 hours after the end of the first infusion; before and 60 minutes after each subsequent infusion
In vivo recovery of fibrinogen
Time frame: 60 minutes, 3 hours, 6 hours and 12 hours after the end of the first infusion; before and 60 minutes after the end of each subsequent infusion and at the time of the overall clinical assessment of hemostatic efficacy
Virus safety markers
Time frame: Day 1 to Day 45
No study locations are listed for this record.
This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fibrinogen
Afibrinogenemia