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

NCT ID: NCT03957356

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2020-07-08

Brief 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.

Detailed 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.

Conditions

Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HLBLS-200

HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.

Group Type: EXPERIMENTAL

HLBLS-200

Intervention Type: DEVICE

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

Interventions

HLBLS-200

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HLB Cell Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongho Choi, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hanyang Univ. Medical Center

Locations

Hanyang Univ. Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LL-MD-01

Identifier Type: -

Identifier Source: org_study_id