ABSTRACT
BACKGROUND: An open-label phase II, multicenter clinical trial was conducted at 11 Haemophilia Centres in Italy, Romania, and Turkey, to evaluate the pharmacokinetics (PK), efficacy, and safety of high purity, plasma-derived, double virus inactivated and double nano-filtered factor IX (pd-FIX) concentrate (Kedrion FIX), EudraCT Number: 2005-006186-14. MATERIAL AND METHODS: 16 previously treated patients (PTPs) with severe or moderately severe haemophilia B were enrolled in the study. At enrolment, 14 underwent the first PK assessment (PK I), and the second PK (PK II) assessment was performed after six months of treatment (5 on-demand and nine prophylaxis) at the end of the study. PK parameters were evaluated by Non-Compartmental Analysis (NCA), One-Compartment model (OCM), and Two-Compartment Model (TCM). Efficacy of Kedrion FIX in all 16 patients was evaluated by the number of bleeding events, and clinical response following the infusions. Periodic FIX inhibitor assays and thrombogenicity tests were scheduled throughout the study to assess the safety of the drug. RESULTS: As compared to the published data on PK of pdFIX, Kedrion FIX displayed a longer half-life (22.37-55.73 hrs), reduced clearance, and regular volume of distribution at PK I by both NCA and OCM. The comparison of outcomes of PK II with those of PK I by OCM, also showed significant changes, particularly in patients on prophylaxis, who showed some improved parameters of PK. Due to two outlier values at the end of the trial, the NCA parameters of PK I were not compared to those of PK II. Breakthrough bleeds were successfully treated with 1 or 2 infusions. No significant adverse events were observed during the study. DISCUSSION: During the six-month clinical study period, the use of Kedrion FIX resulted in a safe and effective pd-FIX concentrate with excellent PK characteristics.
Subject(s)
Factor IX , Hemophilia B , Half-Life , Hemophilia B/drug therapy , Hemorrhage/chemically induced , Humans , TurkeySubject(s)
Factor VIII/genetics , Hemophilia A/genetics , Point Mutation/genetics , Adult , Exons/genetics , Family , Female , Genotype , Humans , Male , Middle Aged , Phenotype , Polymerase Chain Reaction , Sequence Analysis, DNAABSTRACT
Forty children with long-lasting or recurrent conjunctivitis were included in this etiological study. It is well known that purulent conjunctivitis is mainly bacterial, with a major source of infection from Chlamydia; recently, however, a greater percentage of viral forms, with the exception of conjunctivitis without secretion, has been reported. The authors focused their attention on the clinical symptoms and on bacteriological studies of the forms of Chlamydia and Mycoplasma conjunctivitis, highlighting their marked sensitivity to antibiotics and the clinical response and recommending the importance of an etiological study in all cases in which conjunctivitis does not resolve within a short period of time.
Subject(s)
Chlamydia Infections/microbiology , Conjunctivitis/etiology , Child , Child, Preschool , Chlamydia trachomatis/isolation & purification , Conjunctivitis/microbiology , Conjunctivitis/physiopathology , Eye/physiopathology , Eye Diseases/microbiology , Eye Diseases/physiopathology , Female , Humans , Infant , Infant, Newborn , Male , Mycoplasma/isolation & purificationABSTRACT
Psittacosis or ornithosis is a bird disease caused by Chlamydia psittaci which can be transmitted to man. Little is known of the epidemiology of the disease in this region, but occasional cases which have been brought to the authors' attention have prompted an epidemiological study on the subject. The preliminary results indicate a surprising percentage, over 8%, of antibodies in infants and children. This percentage varies little in relation to place of residence, rural or urban, or the presence of animals, but confirms the high risk in parrot-owning households where anti-Chlamydia antibodies are found in 37.5% of children.
Subject(s)
Antibodies, Bacterial/blood , Chlamydophila psittaci/immunology , Adolescent , Animals , Animals, Domestic , Antibody Specificity/immunology , Child , Child, Preschool , Disease Vectors , Humans , Immunoglobulin G/analysis , Infant , Italy/epidemiology , Parrots , Prevalence , Psittacosis/epidemiology , Psittacosis/immunology , Psittacosis/transmission , Seroepidemiologic StudiesSubject(s)
Acquired Immunodeficiency Syndrome/complications , Hemophilia A/complications , Hemophilia B/complications , Herpesviridae Infections/complications , von Willebrand Diseases/complications , Acquired Immunodeficiency Syndrome/immunology , Adolescent , Child , Child, Preschool , Hemophilia A/immunology , Hemophilia B/immunology , Herpesviridae Infections/immunology , Humans , von Willebrand Diseases/immunologySubject(s)
Pneumonia, Mycoplasma/immunology , Respiratory Tract Infections/immunology , Adolescent , Age Factors , Child , Child, Preschool , Female , Humans , Immunoglobulin G/immunology , Immunoglobulin M/immunology , Infant , Male , Pneumonia, Mycoplasma/complications , Pneumonia, Mycoplasma/pathology , Respiratory Tract Infections/etiologyABSTRACT
We studied IFN inducing ability on syngenic C3H mice of a multibacterial antigenic extract consisting of different strains of following species: Staphylococcus aureus, Escherichia coli, Aerobacter aerogenes, Proteus vulgaris. A dose-dependent IFN production was demonstrated and two peaks of circulating IFN were observed few hours and two days after i.v. inoculation. Per os administration only at high doses induced evaluable levels of IFN in the circulation.
Subject(s)
Antigens, Bacterial/administration & dosage , Interferon Inducers , Animals , Enterobacter/immunology , Escherichia coli/immunology , Male , Mice , Mice, Inbred C3H , Proteus vulgaris/immunology , Staphylococcus aureus/immunologyABSTRACT
The hemagglutinating activity of Sindbis virus on untreated or tripsinized blood red cells of some animal species was assessed. In some cases tripsinization increases the red cell sensitivity to viral hemagglutinin. Interferon (IFN) production induced by Sindbis virus on human WISH, mouse L-929 and chicken FEP cells was similar in all three cases. The effects of the temperature on virus replication were studied. Optimal growth was seem to take place at 37 degrees C. These data suggest that the viral pathogenic effect in humans in contrast to the asymptomatic infection in reservoirs is not related to differences in IFN production, but could be due to differences in host body temperature.
