Our Institutions
St. John's Medical College
St. John's College of Nursing
St. John's Allied Health Science
St. John's Medical College Hospital
St. John's Research Institute
SJMCH @Brigade Meadows
St John’s Geriatric Centre
Useful Links
Projects
Pharmacokinetics, efficacy and safety evaluations of a new human plasma derived fibrinogen concentrate (FIB Grifols) in adult patients with congenital afibrinogenemia
Ross CR, Subramanian S, Navarro-Puerto J, Subramanian K, Kalappanavar NK, Khayat CD, Acharya SS, Peyvandi F, Rucker K, Liang W, Vilardell D, Trimm S, Ayguasanosa J. Abstract
Background and aims: Congenital afibrinogenemia is a rare coagulation disorder resulting from a deficiency in fibrinogen. This study assessed the pharmacokinetics, surrogate efficacy and safety of FIB Grifols, a new human plasma-derived fibrinogen concentrate, to treat congenital afibrinogenemia.
Methods: Eleven adult patients from a multinational, phase 1-2, prospective, open-label, single-arm, uncontrolled clinical study received a single infusion of FIB Grifols, 70 mg/kg bw. Fibrinogen pharmacokinetics (fibrinogen activity: Clauss method; antigen plasma concentrations: ELISA) and efficacy parameters were determined over 14 days after infusion. Efficacy endpoints were the mean change on plasma maximum clot firmness (MCF) on viscoelastic testing and coagulation tests 1-hour post-infusion, and correlation with fibrinogen levels throughout. Safety parameters were also assessed.