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

Phase 3

Recruiting

• Conditions: Patients developing heparin resistance during cardiovascular surgery using a cardiopulmonary bypass

• Registration Number: JPRN-jRCT2031230269
• Lead Sponsor: Saiki Yoshikatsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified