At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
Human Plasma-Derived Fibrinogen Concentratebiological
Likely dose
Human Plasma-Derived Fibrinogen Concentrate 1 gfrom 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.
Multicenter, Prospective, Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients With Congenital Afibrinogenemia
In Brief
A Phase 2 clinical trial evaluating Human Plasma-Derived Fibrinogen Concentrate for Congenital Afibrinogenemia. Completed, enrolled 24 participants across 6 sites in 4 countries.
Detailed Summary
The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Afibrinogenemia
CountriesIndia, Italy, Lebanon, United States
CollaboratorsInstituto Grifols, S.A.
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartJul 2016
Primary CompletionNov 2019
TodayJul 2026
First PostedNov 3, 2014
Enrollment StartJul 22, 2016
Primary CompletionNov 11, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.7 years ago
Interventions
Human Plasma-Derived Fibrinogen Concentratebiological
A sterile freeze-dried fibrinogen concentrate filled in vials containing 1 g of FIB Grifols. FIB Grifols contains 20 mg/ml of active substance fibrinogen when reconstituted.