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
CRIS Registration Number |
KCT0002786 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 12 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Hana Pharm |
Organization Type | Pharmaceutical Company |
Project ID | HNP-2001-301 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hana Pharm |
Organization Type | Pharmaceutical Company |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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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 |
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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
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 |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
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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 |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Success rate of general anesthesia |
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Timepoint | from the start of IP administration to the end of IP administration |
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Secondary Outcome(s) 1 | ||
Outcome | Time to loss of consciousness after administration of the investigational product |
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Timepoint | overall study period |
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Secondary Outcome(s) 2 | ||
Outcome | Intra-operative awakening and body movement |
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Timepoint | from the start of IP administration to the end of IP administration |
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Secondary Outcome(s) 3 | ||
Outcome | Time to opening eyes from the end of investigational product administration |
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Timepoint | from the start of IP administration to the end of IP administration |
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Secondary Outcome(s) 4 | ||
Outcome | Controllability of depth of anesthesia |
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Timepoint | from the start of IP administration to the end of study |
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Secondary Outcome(s) 5 | ||
Outcome | Safety Evaluation |
|
Timepoint | from the start of IP administration to the end of study |
11. Study Results and Publication
Result Registered |
Yes
Results Upload |
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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 Statement | No |
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