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Pulmonary TuberculosisPhase 2NCT02836483

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

A Phase 2 study testing LCB01-0371 800mg, QD, LCB01-0371 400mg, BID and LCB01-0371 800mg, BID in people with Pulmonary Tuberculosis, run by LigaChem Biosciences, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Pulmonary Tuberculosis
What is being tested?
LCB01-0371 800mg, QD, LCB01-0371 400mg, BID and LCB01-0371 800mg, BID
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteSouth Korea
Study dates
10 Dec 2016to 1 Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul

Other trials in South Korea

About this study

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

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

Read the detailed description

This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.

Being tested
LCB01-0371 800mg, QD, LCB01-0371 400mg, BID, LCB01-0371 800mg, BID, Tubes 3~5Tablet, QD, Zyvox 600mg, BID
Medical subject headings
Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCB01-0371 800mg, QDDrug

    Also called LCB01-0371

    Oral administration

  • LCB01-0371 400mg, BIDDrug

    Also called LCB01-0371

    Oral administration

  • LCB01-0371 800mg, BIDDrug

    Also called LCB01-0371

    Oral administration

  • Tubes 3~5Tablet, QDDrug

    Also called Tubes Tablet

    Oral administration

  • Zyvox 600mg, BIDDrug

    Also called Zyvox Tablet

    Oral administration

  • LCB01-0371 1200mg, QDDrug

    Also called LCB01-0371

    Oral administration

Study groups in NCT02836483
Study groupRoleWhat they receive
Group 1ExperimentalLCB01-0371 800mg, QD
Receives: Drug: LCB01-0371 800mg, QD
Group 2ExperimentalLCB01-0371 400mg, BID
Receives: Drug: LCB01-0371 400mg, BID
Group 3ExperimentalLCB01-0371 800mg, BID
Receives: Drug: LCB01-0371 800mg, BID
Group 4Active comparatorTubes 3~5Tablet, QD
Receives: Drug: Tubes 3~5Tablet, QD
Group 5Active comparatorZyvox 600mg, BID
Receives: Drug: Zyvox 600mg, BID
Group 6ExperimentalLCB01-0371 1200mg, QD
Receives: Drug: LCB01-0371 1200mg, QD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: V2(Baseline, Day 1), V9(Day 15)

Secondary outcomes (3)

  1. 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

    Measured: V2(Baseline, Day 1), V4(Day 3)

  2. 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

    Measured: V4(Day 3), V9(Day 15)

  3. 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

    Measured: V4(Day 3), V6(Day 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study start10 Dec 2016
  3. Primary completion1 Jul 2019
  4. Study completion1 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02836483
Sponsor's protocol ID
LCB01-0371-15-2-01
Status last verified
Feb 2020
First submitted
5 Jul 2016
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lee SM, Choi SC, Mun KR, Seo JY, Cho YL, Shim TS, Lim HS. Pharmacokinetic and Pharmacodynamic Modeling Analysis of Delpazolid (LCB01-0371) in Adult Patients with Pulmonary Tuberculosis. J Clin Pharmacol. 2024 Jul;64(7):849-859. doi: 10.1002/jcph.2424. Epub 2024 Mar 4.

    PubMed 38436463

  • 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.

    PubMed 34871098

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCB01-0371 800mg, QD, LCB01-0371 400mg, BID and LCB01-0371 800mg, BID in people with Pulmonary Tuberculosis, run by LigaChem Biosciences, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EBA0-14 (time frame: V2(Baseline, Day 1), V9(Day 15)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02836483, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.

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