Pharmacokinetics, efficacy and safety of a novel fibrinogen concentrate in pediatric patients with congenital afibrinogenemia.

Introduction: Congenital afibrinogenemia treatment with plasma-derived fibrinogen concentrates in pediatric patients is limited. This study investigated the pharmacokinetics, surrogate efficacy, and safety of a plasma-derived fibrinogen concentrate (FIB Grifols) in pediatric patients with congenital afibrinogenemia.

Methods: Patients aged <18 years old diagnosed with congenital afibrinogenemia were included in this prospective, multinational, phase 1-2, single-arm study.

Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine in children and adolescents 6 months through 17 years of age in India.

Efficacy and safety data on quadrivalent influenza vaccines (QIVs) for immunization of Indian children are scarce. This phase 3, registration study evaluated the immunogenicity, safety, and tolerability of a QIV in Indian children aged 6-35 months (Group 1) and 3-17 y (Group 2). Subjects received one or two doses (0.

Pharmacokinetics, surrogate efficacy and safety evaluations of a new human plasma-derived fibrinogen concentrate (FIB Grifols) in adult patients with congenital afibrinogenemia.

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.

Carbon particles in airway macrophage as a surrogate marker in the early detection of lung diseases.

Background: It has been shown that inhalation of carbonaceous particulate matter may impair lung function in children.

Objective: Using the carbon content of airway macrophages as a marker of individual exposure to particulate matter derived from fossil fuel, we sought direct evidence for this association.

Methods: 300 children from puffed rice industrial areas and 300 children from population living in green zone were selected randomly.