A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
Primary Purpose
Pulmonary Tuberculosis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LCB01-0371 800mg, QD
LCB01-0371 400mg, BID
LCB01-0371 800mg, BID
Tubes 3~5Tablet, QD
Zyvox 600mg, BID
LCB01-0371 1200mg, QD
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Tuberculosis
Eligibility Criteria
Inclusion Criteria:
- Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
- The age of consent at the time of writing, only men and women under 75 years old over 19 years old
- The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients
Exclusion Criteria:
- Known history of Rifampicin or Isoniazid resistance
- Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
- Known History of nontuberculous mycobacteria positive
- Other pulmonary disease which is impossible to participate in clinical trial except TB
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Arm Description
LCB01-0371 800mg, QD
LCB01-0371 400mg, BID
LCB01-0371 800mg, BID
Tubes 3~5Tablet, QD
Zyvox 600mg, BID
LCB01-0371 1200mg, QD
Outcomes
Primary Outcome Measures
EBA0-14
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15
Secondary Outcome Measures
EBA0-2
The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3
EBA2-14
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15
EBA2-7
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8
Full Information
NCT ID
NCT02836483
First Posted
July 5, 2016
Last Updated
February 4, 2020
Sponsor
LegoChem Biosciences, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02836483
Brief Title
A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
Official Title
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial to Evaluate the EBA, Safety and PK of Orally Administered LCB01-0371 in Adult Patients With Smear-positive Pulmonary Tuberculosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2016 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LegoChem Biosciences, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
Detailed Description
This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
LCB01-0371 800mg, QD
Arm Title
Group 2
Arm Type
Experimental
Arm Description
LCB01-0371 400mg, BID
Arm Title
Group 3
Arm Type
Experimental
Arm Description
LCB01-0371 800mg, BID
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Tubes 3~5Tablet, QD
Arm Title
Group 5
Arm Type
Active Comparator
Arm Description
Zyvox 600mg, BID
Arm Title
Group 6
Arm Type
Experimental
Arm Description
LCB01-0371 1200mg, QD
Intervention Type
Drug
Intervention Name(s)
LCB01-0371 800mg, QD
Other Intervention Name(s)
LCB01-0371
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
LCB01-0371 400mg, BID
Other Intervention Name(s)
LCB01-0371
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
LCB01-0371 800mg, BID
Other Intervention Name(s)
LCB01-0371
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Tubes 3~5Tablet, QD
Other Intervention Name(s)
Tubes Tablet
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Zyvox 600mg, BID
Other Intervention Name(s)
Zyvox Tablet
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
LCB01-0371 1200mg, QD
Other Intervention Name(s)
LCB01-0371
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
EBA0-14
Description
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15
Time Frame
V2(Baseline, Day 1), V9(Day 15)
Secondary Outcome Measure Information:
Title
EBA0-2
Description
The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3
Time Frame
V2(Baseline, Day 1), V4(Day 3)
Title
EBA2-14
Description
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15
Time Frame
V4(Day 3), V9(Day 15)
Title
EBA2-7
Description
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8
Time Frame
V4(Day 3), V6(Day 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
The age of consent at the time of writing, only men and women under 75 years old over 19 years old
The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients
Exclusion Criteria:
Known history of Rifampicin or Isoniazid resistance
Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
Known History of nontuberculous mycobacteria positive
Other pulmonary disease which is impossible to participate in clinical trial except TB
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T.S Sim, M.D., Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34871098
Citation
Kim JS, Kim YH, Lee SH, Kim YH, Kim JW, Kang JY, Kim SK, Kim SJ, Kang YS, Kim TH, Mok J, Byun MK, Park HJ, Joh JS, Park YB, Lim HS, Choi H, Lee SH, Kim H, Yang J, Kim H, Shen X, Alsultan A, Cho I, Geiter L, Shim TS. Early Bactericidal Activity of Delpazolid (LCB01-0371) in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0168421. doi: 10.1128/AAC.01684-21. Epub 2021 Dec 6.
Results Reference
derived
Learn more about this trial
A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
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