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出境医 / 临床实验 / Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Hemorrhage Device: HLBLS-200 Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Arm, Open Label, Single Center Exploratory Clinical Trial
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 19, 2019
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : July 8, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: HLBLS-200
HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.
Device: HLBLS-200
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.

Outcome Measures
Primary Outcome Measures :
  1. Hemostasis at the target blood oozing site [ Time Frame: within 3 minutes ]
    Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application

  2. Adverse Event [ Time Frame: up to 12 weeks ]
    Incidence of Adverse Event after application of HLBLS-200


Secondary Outcome Measures :
  1. Hemostasis at the target blood oozing site [ Time Frame: within 10 minutes ]
    Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application

  2. Time to hemostasis [ Time Frame: within 10 minutes ]
    Time to hemostasis at the target blood oozing site after HLBLS-200 application

  3. Proportion of participants with abnormal laboratory value [ Time Frame: up to 12 weeks ]
    Safety evaluation

  4. Proportion of participants with operation site bleeding after hepatectomy [ Time Frame: up to 12 weeks ]
    Hemorrhage at the operation site


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
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Korea, Republic of
Hanyang Univ. Medical Center
Seoul, Korea, Republic of, 04763
Sponsors and Collaborators
HLB Cell Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Dongho Choi, MD, Ph.D Hanyang Univ. Medical Center
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE June 19, 2019
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Hemostasis at the target blood oozing site [ Time Frame: within 3 minutes ]
    Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application
  • Adverse Event [ Time Frame: up to 12 weeks ]
    Incidence of Adverse Event after application of HLBLS-200
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Hemostasis at the target blood oozing site [ Time Frame: within 10 minutes ]
    Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application
  • Time to hemostasis [ Time Frame: within 10 minutes ]
    Time to hemostasis at the target blood oozing site after HLBLS-200 application
  • Proportion of participants with abnormal laboratory value [ Time Frame: up to 12 weeks ]
    Safety evaluation
  • Proportion of participants with operation site bleeding after hepatectomy [ Time Frame: up to 12 weeks ]
    Hemorrhage at the operation site
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Arm, Open Label, Single Center Exploratory Clinical Trial
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hemorrhage
Intervention  ICMJE Device: HLBLS-200
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
Study Arms  ICMJE Experimental: HLBLS-200
HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.
Intervention: Device: HLBLS-200
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 8, 2020
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957356
Other Study ID Numbers  ICMJE LL-MD-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HLB Cell Co., Ltd.
Study Sponsor  ICMJE HLB Cell Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dongho Choi, MD, Ph.D Hanyang Univ. Medical Center
PRS Account HLB Cell Co., Ltd.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP