Clinical trials: Tuberculosis Active
Pulmonary TB
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
- Trial name
- NCT03678688
- Testing
- 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832
- Where
- 3 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081
This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with…
- Trial name
- WX-081 (NCT04608955)
- Testing
- WX-081, Bedaquiline, Standard treatment
- Where
- China
- Volunteers
- 99 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Pulmonary Tuberculosis
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 of LCB01-0371.
- Trial name
- NCT02836483
- Testing
- LCB01-0371 800mg, QD, LCB01-0371 400mg, BID, LCB01-0371 800mg, BID
- Where
- South Korea
- Volunteers
- 79 people
- Sponsor
- LigaChem Biosciences, Inc.
Tuberculosis Meningitis
Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis
AlpE is a novel drug combination under development for the treatment of TB, with several positive attributes for TBM, including rapid bactericidal activity.
- Trial name
- NCT07350174
- Testing
- HRZE, HRZE plus Alpe375, HRZE plus AlpE500
- Volunteers
- 64 people
- Sponsor
- BioVersys AG
Rheumatoid Arthritis, Crohn's Disease
Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)
This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.
- Trial name
- NCT01577264
- Where
- 45 sites in Russia
- Volunteers
- 199 people
- Sponsor
- UCB Pharma
Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
- Trial name
- NCT03563599
- Testing
- Telacebec (Q203), Rifafour e-275
- Where
- 2 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Qurient Co., Ltd.
Active Tuberculosis, Latent Tuberculosis Infection
Performance Evaluation of the VIDAS TB-IGRA Assay.
This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection.
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Trial name
- NCT04048018
- Testing
- Blood draw and IGRA test
- Where
- 24 sites in United States, Brazil and 7 more
- Volunteers
- 2,401 people, healthy volunteers welcome
- Sponsor
- BioMérieux
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a…
- Trial name
- NCT05537038
- Testing
- BNT164a1, BNT164b1
- Where
- 3 sites in Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
BCG Vaccination Reaction, Tuberculosis
A Study of GC3107(BCG Vaccine) in Healthy Infants
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
- Trial name
- NCT03947138
- Testing
- GC3107, Intradermal BCG SSI inj.
- Where
- 2 sites in South Korea
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with…
- Conditions
- Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
- Trial name
- NCT07170800
- Testing
- JDB0131 100mg, JDB0131 200mg, Delamanid (D)
- Where
- 7 sites in China
- Volunteers
- 60 people
- Sponsor
- WestVac Biopharma Co., Ltd.
Tuberculosis
TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis
The purpose of this study is to assess the effects of 3 different oral doses of TMC207 administered over a 7 day period on the organism that causes tuberculosis
- Trial name
- NCT00523926
- Testing
- TMC207
- Volunteers
- 75 people
- Sponsor
- Tibotec BVBA
Pulmonary Tuberculosis
Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis
Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis
- Trial name
- NCT02467608
- Testing
- Isoniazid with HUEXC030 and RZE, HRZE
- Where
- 18 sites in Taiwan
- Volunteers
- 557 people
- Sponsor
- Orient Pharma Co., Ltd.
Pulmonary Tuberculoses
Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis
A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
- Trial name
- NCT07073638
- Testing
- RESP30TB, HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
- Where
- South Africa
- Volunteers
- 24 people
- Sponsor
- Thirty Respiratory Limited
Tuberculosis
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Multidrug-Resistant
Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less…
- Trial name
- NCT02354014
- Testing
- Bedaquiline (TMC207), Background Regimen (BR)
- Where
- 11 sites in Mozambique, Philippines and 4 more
- Volunteers
- 60 people
- Sponsor
- Janssen Research & Development, LLC
Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant…
- Trial name
- WISH (NCT05824871)
- Testing
- Sudapyridine, Bedaquiline
- Where
- 2 sites in China
- Volunteers
- 450 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Tuberculosis (TB)
Assessing the Ability of the T-SPOT®.TB Test
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response in identifying patients with active TB disease.
- Trial name
- IQ (NCT03929705)
- Where
- South Africa
- Volunteers
- 676 people
- Sponsor
- Oxford Immunotec
Rifampicin Susceptible Pulmonary Tuberculosis
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin…
- Trial name
- NCT06041919
- Testing
- RESP301, HRZE
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- Thirty Respiratory Limited
MAC Lung Disease, Treatment Refractory MAC Lung Disease
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
- Conditions
- MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous
- Trial name
- ICoN-1 (NCT06418711)
- Testing
- Clofazimine Inhalation Suspension
- Where
- 99 sites in United States, Australia and 3 more
- Volunteers
- 132 people
- Sponsor
- Mannkind Corporation
TUBERCULOSIS, PULMONARY
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
- Trial name
- ISIT-TB (NCT04995406)
- Testing
- ISIT-TB prototype
- Where
- South Africa
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- BioMérieux