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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230269
Enrollment
70
Registered
2023-07-29
Start date
2023-10-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass

Interventions

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

Sponsors

Saiki Yoshikatsu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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)).—

Secondary

MeasureTime frame
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))—

Contacts

Public ContactHiroaki Yata

Japan Blood Products Organization

c-development@jbpo.or.jp+81-3-6435-6515

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026