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A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
This study is currently recruiting participants.
Verified August 2017 by LegoChem Biosciences, Inc
Sponsor:
LegoChem Biosciences, Inc
Information provided by (Responsible Party):
LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier:
NCT02836483
First received: July 5, 2016
Last updated: August 28, 2017
Last verified: August 2017
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Purpose
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
| Condition | Intervention | Phase |
|---|---|---|
| Pulmonary Tuberculosis | Drug: LCB01-0371 800mg, QD Drug: LCB01-0371 400mg, BID Drug: LCB01-0371 800mg, BID Drug: Tubes 3~5Tablet, QD Drug: Zyvox 600mg, BID | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by LegoChem Biosciences, Inc:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 64 |
| Actual Study Start Date: | December 10, 2016 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
LCB01-0371 800mg, QD
|
Drug: LCB01-0371 800mg, QD
Oral administration
Other Name: LCB01-0371
|
|
Experimental: Group 2
LCB01-0371 400mg, BID
|
Drug: LCB01-0371 400mg, BID
Oral administration
Other Name: LCB01-0371
|
|
Experimental: Group 3
LCB01-0371 800mg, BID
|
Drug: LCB01-0371 800mg, BID
Oral administration
Other Name: LCB01-0371
|
|
Active Comparator: Group 4
Tubes 3~5Tablet, QD
|
Drug: Tubes 3~5Tablet, QD
Oral administration
Other Name: Tubes Tablet
|
|
Active Comparator: Group 5
Zyvox 600mg, BID
|
Drug: Zyvox 600mg, BID
Oral administration
Other Name: Zyvox Tablet
|
Detailed Description:
This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 70 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02836483
Please refer to this study by its ClinicalTrials.gov identifier: NCT02836483
Contacts
| Contact: T.S. Sim, M.D., Ph.D | 82-2-3010-3892 | shimts@amc.seoul.kr |
Locations
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: T.S. Sim, M.D., Ph.D 82-2-3010-3892 shimts@amc.seoul.kr | |
Sponsors and Collaborators
LegoChem Biosciences, Inc
Investigators
| Principal Investigator: | T.S Sim, M.D., Ph.D | Asan Medical Center |
More Information
| Responsible Party: | LegoChem Biosciences, Inc |
| ClinicalTrials.gov Identifier: | NCT02836483 History of Changes |
| Other Study ID Numbers: |
LCB01-0371-15-2-01 |
| Study First Received: | July 5, 2016 |
| Last Updated: | August 28, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Linezolid Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017