At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 41 enrolled
Drug / intervention
catridecacogdrug
Likely dose
catridecacog 35 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency
In Brief
A Phase 3 clinical trial evaluating catridecacog for Congenital Bleeding Disorder and Congenital FXIII Deficiency. Completed, enrolled 41 participants across 35 sites in 11 countries.
Detailed Summary
The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Finland, France, Germany, Israel, Italy, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartAug 2008
Primary CompletionApr 2010
TodayJul 2026
First PostedJul 11, 2008
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.0 years ago
Interventions
catridecacogdrug
35 IU/kg body weight, i.v. administration, once every 4 weeks