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A multicenter, single-arm, open-label, phase III clinical study to investigate the efficacy and safety of GB-0706 in patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass

A multicenter, single-arm, open-label, phase III clinical study to investigate the efficacy and safety of GB-0706 in patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass

Saiki Yoshikatsu

National University Corporation Tohoku University Tohoku University Hospital

1-1 Seiryocho, Aobaku, Sendai, Miyagi, Japan

kakehi-taito@jbpo.or.jp

Yata Hiroaki

Japan Blood Products Organization

15F Tamachi Station TowerN, 3-1-1 Shibaura, Minato-ku, Tokyo, Japan

+81-3-6435-6515

kakehi-taito@jbpo.or.jp

Not Recruiting

Aug. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. 18 years old or older and 85 years or younger at the time when informed consent is obtained
2. Receiving elective cardiovascular surgery using a cardiopulmonary bypass
3. Platelet count of 178,000 / microliter or more at laboratory tests at screening
4. Fibrinogen count of 264 mg/dL or more at laboratory tests at screening
5. Meeting all the inclusion criteria 1 to 4 and found to have Heparin Resistance according to the definition of Heparin Resistance specified in this study

1. Having been administered a specified prohibited concomitant drug or prohibited concomitant therapy before administration of the study drug
2. Having congenital antithrombin III deficiency
3. Having a history of heparin-induced thrombocytopenia
4. Having a history of antiphospholipid syndrome
5. Receiving surgery other than cardiovascular surgery at the same time
6. Found to have a history of coagulation disorder (such as von Willebrand disease) for reasons such as a medical history of hemorrhagic disease or test history
7. Having congenital or acquired coagulation factor deficiency or abnormality

Both

Patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass

GB-0706 will be administered as the quantity of a single dose is 1,500 IU of antithrombin. If Heparin resistance does not improve after administration of study drug one dose, an additional dose, study drug dose will be administered.
(A maximum dose is 3,000 IU)

The percentage of subjects with ACT 480 seconds or over (improved Heparin resistance) after administration of the study drug (study drug dose (1), or, if the study drug is administered twice, study drug dose (2)).

The change in ACT from the additional dose of heparin to after administration of the study drug (study drug dose (1), or, if the study drug is administered twice, study drug dose (2))

July. 25, 2023

No

none