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A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

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ClinicalTrials.gov Identifier: NCT02836483
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
LegoChem Biosciences, Inc

Tracking Information
First Submitted Date  ICMJE July 5, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE December 10, 2016
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
EBA0-14 [ Time Frame: V2(Baseline, Day 1), V9(Day 15) ]
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
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), V9(Day 15) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
  • EBA0-2 [ Time Frame: V2(Baseline, Day 1), V4(Day 3) ]
    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 [ Time Frame: V4(Day 3), V9(Day 15) ]
    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 [ Time Frame: V4(Day 3), V6(Day 8) ]
    The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • 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), V4(Day 3) ]
  • The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 15 [ Time Frame: V4(Day 2), V9(Day 15) ]
  • 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 2), V6(Day 8) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Tuberculosis
Intervention  ICMJE
  • Drug: LCB01-0371 800mg, QD
    Oral administration
    Other Name: LCB01-0371
  • Drug: LCB01-0371 400mg, BID
    Oral administration
    Other Name: LCB01-0371
  • Drug: LCB01-0371 800mg, BID
    Oral administration
    Other Name: LCB01-0371
  • Drug: Tubes 3~5Tablet, QD
    Oral administration
    Other Name: Tubes Tablet
  • Drug: Zyvox 600mg, BID
    Oral administration
    Other Name: Zyvox Tablet
  • Drug: LCB01-0371 1200mg, QD
    Oral administration
    Other Name: LCB01-0371
Study Arms  ICMJE
  • Experimental: Group 1
    LCB01-0371 800mg, QD
    Intervention: Drug: LCB01-0371 800mg, QD
  • Experimental: Group 2
    LCB01-0371 400mg, BID
    Intervention: Drug: LCB01-0371 400mg, BID
  • Experimental: Group 3
    LCB01-0371 800mg, BID
    Intervention: Drug: LCB01-0371 800mg, BID
  • Active Comparator: Group 4
    Tubes 3~5Tablet, QD
    Intervention: Drug: Tubes 3~5Tablet, QD
  • Active Comparator: Group 5
    Zyvox 600mg, BID
    Intervention: Drug: Zyvox 600mg, BID
  • Experimental: Group 6
    LCB01-0371 1200mg, QD
    Intervention: Drug: LCB01-0371 1200mg, QD
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: February 4, 2020)
79
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
30
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
  2. The age of consent at the time of writing, only men and women under 75 years old over 19 years old
  3. The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients

Exclusion Criteria:

  1. Known history of Rifampicin or Isoniazid resistance
  2. Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
  3. Known History of nontuberculous mycobacteria positive
  4. Other pulmonary disease which is impossible to participate in clinical trial except TB
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 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 NCT02836483
Other Study ID Numbers  ICMJE LCB01-0371-15-2-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LegoChem Biosciences, Inc
Study Sponsor  ICMJE LegoChem Biosciences, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: T.S Sim, M.D., Ph.D Asan Medical Center
PRS Account LegoChem Biosciences, Inc
Verification Date February 2020

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