Pharmacokinetics and tolerability evaluation of human coagulation recombinant factor VIII (Greengenetm™) in hemophilia a patients

Hye Kyung Han; 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

doi:10.12793/jkscpt.2011.19.2.144

Pharmacokinetics and tolerability evaluation of human coagulation recombinant factor VIII (Greengenetm™) in hemophilia a patients

Hye Kyung Han, 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

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Background: GreenGene™ (Green Cross Corp.) is a recombinant clotting factor vii 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™ 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™ or GreenMono™(active control) intravenously on day 1 and every other day from day 4 to 10. Fvii:C (Factor vii 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 (C_max) and the area under the concentration-time curve (AUC_0-48) of the GreenGene™ 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 C_max and AUC_0-48 in steady state of the GreenGene™ 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™ to hemophilia A patients appeared to be well tolerated within range of 25-50 IU/kg. The PK parameters of factor vii showed dose-independent manner with 25 IU/kg and 50 IU/kg dose ranges.

Original language	English
Pages (from-to)	144-151
Number of pages	8
Journal	Journal of Korean Society for Clinical Pharmacology and Therapeutics
Volume	19
Issue number	2
DOIs	https://doi.org/10.12793/jkscpt.2011.19.2.144
State	Published - Dec 2011

Keywords

Hemophilia A
Korean
Pharmacokinetics
Recombinant factor VIII

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10.12793/jkscpt.2011.19.2.144

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Han, H. K., Shin, K. H., Paik, S. H., Chung, J. Y., Lim, K. S., Cho, J. Y., Yoon, S. H., Shin, S. G., Jang, I. J., & Yu, K. S. (2011). Pharmacokinetics and tolerability evaluation of human coagulation recombinant factor VIII (Greengenetm™) in hemophilia a patients. Journal of Korean Society for Clinical Pharmacology and Therapeutics, 19(2), 144-151. https://doi.org/10.12793/jkscpt.2011.19.2.144

@article{7439ffb8c7874c09bb53a6ba34f5cbc5,

title = "Pharmacokinetics and tolerability evaluation of human coagulation recombinant factor VIII (Greengenetm{\texttrademark}) in hemophilia a patients",

abstract = "Background: GreenGene{\texttrademark} (Green Cross Corp.) is a recombinant clotting factor vii 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{\texttrademark} 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{\texttrademark} or GreenMono{\texttrademark}(active control) intravenously on day 1 and every other day from day 4 to 10. Fvii:C (Factor vii 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{\texttrademark} 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{\texttrademark} 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{\texttrademark} to hemophilia A patients appeared to be well tolerated within range of 25-50 IU/kg. The PK parameters of factor vii showed dose-independent manner with 25 IU/kg and 50 IU/kg dose ranges.",

keywords = "Hemophilia A, Korean, Pharmacokinetics, Recombinant factor VIII",

author = "Han, {Hye Kyung} and Shin, {Kwang Hee} and Paik, {Sang Hoon} and Chung, {Jae Yong} and Lim, {Kyoung Soo} and Cho, {Joo Youn} and Yoon, {Seo Hyun} and Shin, {Sang Goo} and Jang, {In Jin} and Yu, {Kyung Sang}",

year = "2011",

month = dec,

doi = "10.12793/jkscpt.2011.19.2.144",

language = "English",

volume = "19",

pages = "144--151",

journal = "Journal of Korean Society for Clinical Pharmacology and Therapeutics",

issn = "1225-5467",

publisher = "Korean Society Clinical Pharmacology and Therapeutics",

number = "2",

}

Han, HK, Shin, KH, Paik, SH, Chung, JY, Lim, KS, Cho, JY, Yoon, SH, Shin, SG, Jang, IJ & Yu, KS 2011, 'Pharmacokinetics and tolerability evaluation of human coagulation recombinant factor VIII (Greengenetm™) in hemophilia a patients', Journal of Korean Society for Clinical Pharmacology and Therapeutics, vol. 19, no. 2, pp. 144-151. https://doi.org/10.12793/jkscpt.2011.19.2.144

TY - JOUR

T1 - Pharmacokinetics and tolerability evaluation of human coagulation recombinant factor VIII (Greengenetm™) in hemophilia a patients

AU - Han, Hye Kyung

AU - Shin, Kwang Hee

AU - Paik, Sang Hoon

AU - Chung, Jae Yong

AU - Lim, Kyoung Soo

AU - Cho, Joo Youn

AU - Yoon, Seo Hyun

AU - Shin, Sang Goo

AU - Jang, In Jin

AU - Yu, Kyung Sang

PY - 2011/12

Y1 - 2011/12

N2 - Background: GreenGene™ (Green Cross Corp.) is a recombinant clotting factor vii 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™ 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™ or GreenMono™(active control) intravenously on day 1 and every other day from day 4 to 10. Fvii:C (Factor vii 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™ 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™ 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™ to hemophilia A patients appeared to be well tolerated within range of 25-50 IU/kg. The PK parameters of factor vii showed dose-independent manner with 25 IU/kg and 50 IU/kg dose ranges.

AB - Background: GreenGene™ (Green Cross Corp.) is a recombinant clotting factor vii 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™ 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™ or GreenMono™(active control) intravenously on day 1 and every other day from day 4 to 10. Fvii:C (Factor vii 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™ 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™ 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™ to hemophilia A patients appeared to be well tolerated within range of 25-50 IU/kg. The PK parameters of factor vii showed dose-independent manner with 25 IU/kg and 50 IU/kg dose ranges.

KW - Hemophilia A

KW - Korean

KW - Pharmacokinetics

KW - Recombinant factor VIII

UR - http://www.scopus.com/inward/record.url?scp=84861316238&partnerID=8YFLogxK

U2 - 10.12793/jkscpt.2011.19.2.144

DO - 10.12793/jkscpt.2011.19.2.144

M3 - Article

AN - SCOPUS:84861316238

SN - 1225-5467

VL - 19

SP - 144

EP - 151

JO - Journal of Korean Society for Clinical Pharmacology and Therapeutics

JF - Journal of Korean Society for Clinical Pharmacology and Therapeutics

IS - 2

ER -

Pharmacokinetics and tolerability evaluation of human coagulation recombinant factor VIII (Greengenetm™) in hemophilia a patients

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