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A Randomized, Multi-center, Parallel group, Active comparator, Single blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HNP-2001in Surgical Patients undergoing General Anesthesia

Status Approved

  • First Submitted Date

    2018/02/21

  • Registered Date

    2018/04/11

  • Last Updated Date

    2020/11/03

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002786
    Unique Protocol ID HNP-2001-301
    Public/Brief Title Phase III Clinical Trial to Evaluate the Efficacy and Safety of HNP-2001 in Surgical Patients undergoing General Anesthesia
    Scientific Title A Randomized, Multi-center, Parallel group, Active comparator, Single blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HNP-2001in Surgical Patients undergoing General Anesthesia
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number H-1712-064-905
    Approval Date 2017-12-20
    Institutional Review Board Name Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board
    Institutional Review Board Address 103, Daehak-ro, Jongno-gu, Seoul
    Institutional Review Board Telephone 02-2072-0694
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jae-hyon Bahk
    Title Professor
    Telephone +82-2-1588-5700
    Affiliation Seoul National University Hospital
    Address 101,Daehak-ro, Jongno-gu, Seoul 03080, Korea
    Contact Person for Public Queries
    Name Jeong-Hwa Seo
    Title Professor
    Telephone +82-2-1588-5700
    Affiliation Seoul National University Hospital
    Address 101,Daehak-ro, Jongno-gu, Seoul 03080, Korea
    Contact Person for Updating Information
    Name Minhui Kim
    Title ACOM
    Telephone +82-2-559-5769
    Affiliation Hana Pharm
    Address 10th Floor, EK Tower, 407 Teheran-Ro, Gangnam-Gu, Seoul, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 12
    Overall Recruitment Status Completed
    Date of First Enrollment 2018-03-22 Actual
    Target Number of Participant 198
    Primary Completion Date 2018-10-06 , Actual
    Study Completion Date 2018-12-12 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-06-19 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Asan Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2018-03-22 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Yonsei University Health System, Gangnam Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-05-17 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Kyungpook National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-05-16 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Koera University Guro Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-03-30 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Pusan National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-04-19 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Samsung Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2018-04-25 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Inje University Sanggye Paik Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-04-03 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Seoul National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-03-28 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-05-15 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Ajou University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-04-23 ,
    Recruitment Status by Participating Study Site 12
    Name of Study Chonnam National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-04-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hana Pharm
    Organization Type Pharmaceutical Company
    Project ID HNP-2001-301
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hana Pharm
    Organization Type Pharmaceutical Company
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The purpose of this study is to evaluate the efficacy and the safety of HNP-2001 (study drug) vs. Propofol (control) for the induction and the maintenance of general anesthesia in patients undergoing elective surgery with general anesthesia and this study  will be a multi-center, randomized, parallel design and single-blind study.
    Efficacy and safety endpoints will be evaluated throughout the study, and the study will be ended after the tests to be conducted 24 hours from the end of investigational product administration according to Time and Events Schedule are completed.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase3
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    [Investigational product]
    Study drug: HNP-2001 50 mg
    Control drug: Propofol 10 mg/mL 
    [Duration of administration] 1 day
    [Mode of study drug administration]
    Study drug will be administered by intravenous infusion at dose of 6 mg/kg/h until loss of consciousness. After loss of consciousness, intravenous infusion of study drug at dose of 1 mg/kg/h will be started. And then, the infusion rate (maximum allowed dose 2 mg/kg/h) will be adjusted appropriately based on the monitoring of each subjects' general condition until the end of surgery.
    
    [Mode of control drug administration]
    In subjects less than 55 years of age, control drug 40 mg will be administered intravenously every 10 seconds by bolus or intravenous infusion at dose of 1.5 - 2.5 mg/kg until loss of consciousness, and the total dose can be reduced by lower rate of administration (20 ~ 50 mg/min). In subjects 55 years of age or older, control drug 20 mg will be administered by intravenous infusion every 10 seconds at dose of 1 ~ 1.5 mg/kg until loss of consciousness (bolus administration should not be used).
    
    After loss of consciousness, intravenous infusion of control drug at usual dose of 4 - 12 mg/kg/hr (3 - 6 mg/kg/hr for subjects 55 years of age or older) will be started. And then, the infusion rate will be adjusted appropriately based on the monitoring of each subjects' general condition until the end of surgery.
    Number of Arms 2
    Arm 1

    Arm Label

    Study drug(HNP-2001)

    Target Number of Participant

    99

    Arm Type

    Experimental

    Arm Description

    Study drug will be administered by intravenous infusion at dose of 6 mg/kg/h until loss of consciousness. After loss of consciousness, intravenous infusion of study drug at dose of 1 mg/kg/h will be started. And then, the infusion rate will be adjusted appropriately based on the monitoring of each subjects' general condition until the end of surgery.
    Arm 2

    Arm Label

    Control drug(Propofol)

    Target Number of Participant

    99

    Arm Type

    Active comparator

    Arm Description

    In subjects less than 55 years of age, control drug 40 mg will be administered intravenously every 10 seconds by bolus or intravenous infusion at dose of 1.5 - 2.5 mg/kg until loss of consciousness, and the total dose can be reduced by lower rate of administration (20 ~ 50 mg/min). In subjects 55 years of age or older, control drug 20 mg will be administered by intravenous infusion every 10 seconds at dose of 1 ~ 1.5 mg/kg until loss of consciousness (bolus administration should not be used).
    
    After loss of consciousness, intravenous infusion of control drug at usual dose of 4 - 12 mg/kg/hr (3 - 6 mg/kg/hr for subjects 55 years of age or older) will be started. And then, the infusion rate will be adjusted appropriately based on the monitoring of each subjects' general condition until the end of surgery.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (T81.8)Other complications of procedures, NEC 

    Anesthesia, Intravenous(E03.155.308) Process of administering an anesthetic through injection directly into the bloodstream
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    1)	Male or female ≥ 18 years of age at the day of consent
    2)	Patients scheduled for surgery requiring ventilator with endotracheal intubation
    3)	American Society of Anesthesiologists (ASA) Physical status Ⅰ or Ⅱ
    4)	Patients who voluntarily choose to participate in the study and sign a written informed consent form
    Exclusion Criteria
    1)	Patients scheduled to have local anesthesia (spinal subarachnoid anesthesia, epidural anesthesia, peripheral nerve block) between Day 1 operating room entrance and the end of endotracheal intubation
    2)	Planned to have hepatic resection or liver transplantation during the surgery
    3)	Planned to use heart-lung machine during the surgery (e.g., cardiotomy, heart transplantation, lung transplantation, etc.)
    4)	Uncontrolled hypertension (SBP ≥ 180 mmHg [≥ 160 mmHg for patients taking anti-hypertensives] at screening)
    5)	Uncontrolled diabetes mellitus (HbA1c ≥ 9% at screening)
    6)	Patients with chronic obstructive pulmonary disease requiring treatment or patients who require the maintenance of endotracheal intubation for post-operative respiration management expected to result in difficulty in immediate removal of intubation
    7)	Resistance to benzodiazepines
    8)	Hypersensitivity to benzodiazepines, propofol, remifentanil, fentanil citrate, rocuronium bromide, sugammadex, flumazenil, and other anesthetics
    9)	Investigator otherwise judges that the patient is not eligible for the study participation
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Success rate of general anesthesia
    Timepoint
    from the start of IP administration to the end of IP administration
    Secondary Outcome(s) 1
    Outcome
    Time to loss of consciousness after administration of the investigational product
    Timepoint
    overall study period
    Secondary Outcome(s) 2
    Outcome
    Intra-operative awakening and body movement
    Timepoint
    from the start of IP administration to the end of IP administration
    Secondary Outcome(s) 3
    Outcome
    Time to opening eyes from the end of investigational product administration
    Timepoint
    from the start of IP administration to the end of IP administration
    Secondary Outcome(s) 4
    Outcome
    Controllability of depth of anesthesia
    Timepoint
    from the start of IP administration to the end of study
    Secondary Outcome(s) 5
    Outcome
    Safety Evaluation
    Timepoint
    from the start of IP administration to the end of study
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Results Upload
    Final Enrollment Number 198
    Number of Publication 0
    Results Upload HNP-2001-301_연구결과.pdf
    Date of Posting Results 2020/11/03
    Protocol URL or File Upload
    Brief Summary
    The purpose of this study is to evaluate the efficacy and the safety of HNP-2001 (study drug) vs. Propofol (control) for the induction and the maintenance of general anesthesia in patients undergoing elective surgery with general anesthesia.
    In the primary efficacy evaluation, the success rate of general anesthesia was similar in the HNP-2001group and the comparator group.There was no statistically significant difference in the incidence of localized adverse events and of excluded localized adverse events in the HNP-2001 and comparator groups. Also, there was no serious adverse event occurred. These results confirm the efficacy and safety of the HNP-2001 for the induction and maintenance of general anesthesia in surgical patients, and it is expected to act as an anesthetic drugs that does not cause circulatory system problems.
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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