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

Pulmonary Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836483
• Other study ID #: LCB01-0371-15-2-01
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2020
• Source: LegoChem Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• LCB01-0371 800mg, QD
Oral administration
• LCB01-0371 400mg, BID
Oral administration
• LCB01-0371 800mg, BID
Oral administration
• Tubes 3~5Tablet, QD
Oral administration
• Zyvox 600mg, BID
Oral administration
• LCB01-0371 1200mg, QD
Oral administration

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LegoChem Biosciences, Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	V2(Baseline, Day 1), V9(Day 15)
Secondary	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	V2(Baseline, Day 1), V4(Day 3)
Secondary	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	V4(Day 3), V9(Day 15)
Secondary	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	V4(Day 3), V6(Day 8)