Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique

Hemorrhage Clinical Trial

Official title:

Single Center, Single Arm, Open-label, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique for Oozing Hemorrhage During Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957356
• Other study ID #: LL-MD-01
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: July 8, 2020

Study information

• Verified date: July 2020
• Source: HLB Cell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label, exploratory clinical trial designed to investigate the safety and efficacy of HLBLS-200 (an investigational hemostatic agent). The study will recruit approximately 8 subjects.

Description:

Patients scheduled for hepatic resection who voluntarily agree to participate the study will be recruited for the screening procedures.

Patients who meet the eligibility criteria will be assigned to the study. Subjects will receive HLBLS-200 as a supplementary hemostatic technique for oozing hemorrhage which can be occurred during hepatic resection.

A dose of HLBLS-200 based on the area of liver resection will be applied and time to hemostasis of blood oozing will be evaluated.

Patients will be followed for 12 weeks after application of HLBLS-200 to monitor any adverse event.

Study objective:

1. To investigate the safety of HLBLS-200 application.

2. To explore hemostatic function of HLBLS-200 in patients receiving hepatectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 8, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria: (during screening period)

• Subject aged between 18 and 80 years old and scheduled for non-emergent hepatic resection.

• Subject is willing to provide written consent and able to comply with study procedures.

• Female subject of childbearing potential who is willing to use an adequate method of contraception or to be abstinent during the course of the study.

Inclusion Criteria: (during hepatectomy)

• Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.

Exclusion Criteria: (during screening period)

• Subject with a history of bleeding disorder, platelet disorder or bone marrow disorder.

• Platelet count < 50 X 10^9/L or International normalized ratio > 2.

• Subject who received any drug affecting hemorrhage and/or hemostasis such as anticoagulants, antiplatelet agents or thrombolytic agent within 2 weeks prior to hepatectomy.

• Subject with a history of hypersensitivity to the substance of the investigational device.

• Creatinine clearance < 30mL/min

• Aspartate transaminase or alanine aminotransferase = 3.0 X upper limit of normal.

• Subject with a suspected disorder of decrease in fibrinolytic activity such as disseminated intravascular coagulation.

• Subject with a history of alcohol or drug abuse.

• Pregnant or lactating women

• Subject who have participated in other clinical trial and have received investigation drugs or devices within 4 weeks prior to participation in the study.

• Subject who were judged by the investigator as inadequate for participation in the study.

Exclusion Criteria: (during hepatectomy)

• Subject with following major bleeding (e.g. spurting hemorrhage, hemorrhage from hepatic veins) despite application of primary hemostatic methods

• Subject who is deemed to need anticoagulant treatment within 48 hours of hepatectomy.

• For other reason, subject who were judged by the investigator as inadequate for participation in the study.

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Device:
• HLBLS-200
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang Univ. Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HLB Cell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis at the target blood oozing site	Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application	within 3 minutes
Primary	Adverse Event	Incidence of Adverse Event after application of HLBLS-200	up to 12 weeks
Secondary	Hemostasis at the target blood oozing site	Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application	within 10 minutes
Secondary	Time to hemostasis	Time to hemostasis at the target blood oozing site after HLBLS-200 application	within 10 minutes
Secondary	Proportion of participants with abnormal laboratory value	Safety evaluation	up to 12 weeks
Secondary	Proportion of participants with operation site bleeding after hepatectomy	Hemorrhage at the operation site	up to 12 weeks