BACKGROUND: Continuous infusion of factor VIII (FVIII) is a more cost-effective method for treating hemophilia A than intermittent bolus injection. However, there is currently no specific data in Korea about the progress of in vitro FVIII coagulant activity (FVIII:C) after reconstitution from its lyophilized form. METHODS: Three commercial FVIII concentrate products (two recombinant FVIII and one plasma-derived) were used. In vitro FVIII:C was measured at 0, 2, 4, 6, and 8 hours following reconstitution in both the indoor light-exposed and light-shielded groups. RESULTS: For the three drugs, in vitro FVIII:C decreased over the 8 hours following reconstitution (P<0.001). The decline of FVIII:C was linear (P<0.001). In vitro FVIII:C for the indoor light-exposed groups was 95.3+/-1.9% and 90.6+/-2.5% after 4 and 8 hours following reconstitution, respectively, compared to baseline activity. In the light-shielded group, FVIII:C was 95.4+/-1.1% and 90.9+/-1.7% of the baseline activity after 4 and 8 hours, respectively. There was no statistical difference between FVIII:C in the indoor light-exposed and light-shielded groups (P=0.849). CONCLUSION: In vitro FVIII:C decreased after reconstitution, but activity was maintained at over 90% of the baseline value during 8 hours. Exposure to indoor light did not accelerate the loss of FVIII:C over the experimental time. This result indicates that CI with FVIII is available in 8-hour intervals, with no indoor light-exposure precautions needed.
Factor VIII* ; Hemophilia A ; Korea

No abstract available.
Factor VIII* ; Hemophilia A* ; Humans

BACKGROUND: GreenGene(TM) (Green Cross Corp.) is a recombinant clotting factor VIII which is used for hemophilia A. This study aimed to investigate the pharmacokinetics and safety profiles of 25 IU/kg and 50 IU/kg of GreenGene(TM) in Korean hemophilia A patients. METHODS: A dose-block randomized, single-blind, active drug-controlled, single and multiple dose, parallel-group study was conducted with 16 hemophilia A patients (25 IU/kg: 50 IU/kg = 8:8). They received GreenGene(TM) or GreenMono(TM)(active control) intravenously on day 1 and every other day from day 4 to 10. FVIII:C (Factor VIII procoagulant activity) was measured to determine the pharmacokinetics (PK) at baseline and up to 48 hours for single and multiple administration. PK parameters were determined using noncompartmental methods. RESULTS: The maximum concentration (Cmax) and the area under the concentration-time curve (AUC0-48) of the GreenGene(TM) 25 IU/kg (mean +/- SD) were 59.00 +/- 19.26 % and 774.40 +/- 380.13 %.h respectively, while those of 50 IU/kg were 131.50 +/- 39.81 % and 1462.44 +/- 397.09 %.h after single administration. The Cmax and AUC0-48 in steady state of the GreenGene(TM) 25 IU/kg were 68.17 +/- 22.75 % and 863.30 +/- 334.40 %.h, while those of 50 IU/kg were 147.17 +/- 18.47 % and 1820.08 +/- 704.42 %.h. No serious adverse event was observed. CONCLUSION: The GreenGene(TM) to hemophilia A patients appeared to be well tolerated within range of 25-50 IU/kg. The PK parameters of factor VIII showed dose-independent manner with 25 IU/kg and 50 IU/kg dose ranges.
Factor VIII ; Hemophilia A ; Humans

Plasma is separated fresh unit of whole blood in closed system. The plasma is frozen in system that will allow complete freezing within one hour to a temperature below-350C. The plasma is thawed slowly at 1-60 C for 18 h and centrifuged at 1-60 C. Final volume for cryoprecipitate concentrate is 10-20/ml. Result: 140 samples during 2 years 95.57% FVIII > 70IU/unit. 4.43% F VIII > 45 IU to 68 IU /unit. During 2 years 1999 to 2000 hospitals in HCM city have used 5,675 F VIII rich cryoprecipitate unit for treatment Hemophilia A, DIC, fibrinogen defects. Side effects as mainly chills, fever and urticaria have not reported. Results of treatment are very good and safe for patients.
Factor VIII ; Utilization

51 blind people in childbearing age who had married were involved in this survey. Findings showed that the rate of using contraceptive methods in blind people is 70.5%. For blind people who have high-school level in education and who were received family planing communication, the rate of using contraceptive methods is higher. Rate of blind people who have 3 children or more is 17.6%. Rate of abortion in blind people is 11.8% and rate of blind people who knew at least one contraceptive method is 92.2%.
Factor VIII ; Utilization

No abstract available.
Factor VIII* ; Prevalence*

No abstract available.
Factor VIII* ; Polymorphism, Restriction Fragment Length*

Background: Hemophilia A is a genetic bleeding disorder that results from a deficiency in factor VIII. The prevalence of Hemophilia in Vietnam is rather high (2/34830 people) and Vietnam has high usage demand for factor VIII in the treatment and prevention of the disease. Therefore, it is necessary to study and produce recombinant blood \u2013 coagulation factor WIII. Objective: To clone successfully A1A2 and A3C2 gen fragment encoding factor VIII. Subject and Method: Amplify A1A2 and A3C2 gene fragments by PCR from human cDNA. PCR products were ligated into cloning vector pQE \u2013 30UA. Recombinant plasmids were transformed into E.coli DH5 alpha host strain. Inserted A1A2 and A3C2 gene fragments were checked by PCR and restriction enzymes. Result: Successfully amplifying functional gene fragments encoding factor VIII using specific primers. Conclusion: Obtaining pQE \u2013 30UA vector carrying A1A2 and A3C2 fragments encoding factor VIII. This is the premise result for the next studies on synthesis of recombinant factor WIII and application of genetic therapy.
Hemophilia ; Blood \u2013 coagulation factor VIII

BACKGROUND: New B-domain deleted third generation recombinant factor VIII (FVIII; GreenGene F™, beroctocog alfa) was launched in 2010. We determined safety and efficacy of GreenGene F™ during routine clinical practice in patients with hemophilia A over a period of 12 months. METHODS: From July 2010 to July 2014, a total of 136 hemophilia A patients were enrolled in a post-marketing surveillance (PMS) study. Among them, 134 patients were assessed for drug safety and 114 patients were analyzed for drug efficacy. Patients with differing hemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. RESULTS: Among 134 patients evaluated, 85 (63.4%) had severe hemophilia. Ninety-two received a total of 1,266,077 units for prophylaxis, and 42 received 516,491 units for bleeding episodes. Three patients developed inhibitors. In 112 previously treated patients, one patient (0.9%) developed inhibitor after intensive FVIII treatment for surgery. Among 22 previously untreated patients, inhibitors were observed in 2 infants (9.1%). Overall, there were a total of 47 adverse events (other than inhibitors) of all types in 30 patients (22.4%), 11 in 10 patients (7.5%) of which were considered showing serious adverse events (SAEs); most of which were hemorrhages at different sites. None of the SAEs were judged as product related. An excellent/good efficacy rate of 91.3% for hemostasis and 89.4% for hemorrhage prevention was recorded. CONCLUSION: The results of this PMS study support the use of GreenGene F™ as safe and efficacious in hemorrhage prevention and treatment of hemophilia A. These results are consistent with the findings from previously published GreenGene F™ studies.
Factor VIII ; Hemophilia A ; Hemorrhage ; Hemostasis ; Humans ; Infant

Asians ; China ; Factor VIII ; Hemophilia A/therapy* ; Humans