Pharmacokinetics and Tolerability Evaluation of Human Coagulation Recombinant Factor VIII (GreenGene(TM)) in Hemophilia A Patients.
- Author:
HyeKyung HAN
1
;
Kwang Hee SHIN
;
Sang Hoon PAIK
;
Jae Yong CHUNG
;
Kyoung Soo LIM
;
Joo Youn CHO
;
Seo Hyun YOON
;
Sang Goo SHIN
;
In Jin JANG
;
Kyung Sang YU
Author Information
1. Department of Pharmacology and Clinical Pharmacology, Seoul National University College of Medicine and Hospital, Seoul, Korea. ksyu@snu.ac.kr
- Publication Type:Randomized Controlled Trial ; Original Article
- Keywords:
Hemophilia A;
Recombinant factor VIII;
Pharmacokinetics;
Korean
- MeSH:
Factor VIII;
Hemophilia A;
Humans
- From:Journal of Korean Society for Clinical Pharmacology and Therapeutics
2011;19(2):144-151
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
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.
