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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 : Recruiting
First Posted : July 19, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
LegoChem Biosciences, Inc

July 5, 2016
July 19, 2016
April 10, 2018
December 10, 2016
October 2018   (Final data collection date for primary outcome measure)
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
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) ]
Complete list of historical versions of study NCT02836483 on ClinicalTrials.gov Archive Site
  • 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
  • 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) ]
Not Provided
Not Provided
 
A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
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
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Tuberculosis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
30
December 2018
October 2018   (Final data collection date for primary outcome measure)

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 70 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
Sexes Eligible for Study: All
19 Years to 70 Years   (Adult, Older Adult)
No
Contact: T.S. Sim, M.D., Ph.D 82-2-3010-3892 shimts@amc.seoul.kr
Korea, Republic of
 
 
NCT02836483
LCB01-0371-15-2-01
No
Not Provided
Plan to Share IPD: No
LegoChem Biosciences, Inc
LegoChem Biosciences, Inc
Not Provided
Principal Investigator: T.S Sim, M.D., Ph.D Asan Medical Center
LegoChem Biosciences, Inc
August 2017

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