Clinical trials: Mycobacterium Tuberculous
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.
Multidrug-resistant Tuberculosis
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.
- Trial name
- NCT01424670
- Testing
- Delamanid + OBR
- Where
- 17 sites in Estonia, Latvia and 5 more
- Volunteers
- 511 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.
- Trial name
- NCT01999231
- Testing
- ESAT6-CFP10
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days.
- Trial name
- NCT00990990
- Testing
- PNU-100480, Linezolid
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
Tuberculosis
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65
The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and…
- Trial name
- IIb-healthy (NCT02389322)
- Testing
- 5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10, BCG
- Where
- China
- Volunteers
- 1,044 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Latent Tuberculosis Infection
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients.
- Trial name
- NCT05746611
- Testing
- Recombinant Mycobacterium tuberculosis fusion protein for injection, TB-PPD was injected
- Where
- China
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Tuberculosis remains a concerning health problem, with Mycobacterium Tuberculosis (MTB) now causing more deaths than acquired immune deficiency syndrome (AIDS).
- Trial name
- NCT03557281
- Testing
- GSK3036656, Rifafour e-275
- Where
- South Africa
- Volunteers
- 76 people
- Sponsor
- GlaxoSmithKline
Lung Cancer, Small Cell Lung Cancer
A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method…
- Conditions
- Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma
- Trial name
- NCT05337163
- Testing
- Diagnostic Test: Sputum DNA methylation analysis, chest CT or pathological examination
- Where
- China
- Volunteers
- 1,564 people, healthy volunteers welcome
- Sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.
Tuberculosis, Multidrug Resistant
Safety of RUTI® Vaccination in MDR-TB Patients
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant Tuberculosis (MDR-TB) patients favourably responding to…
- Trial name
- NCT02711735
- Testing
- RUTI® Therapeutic vaccine
- Where
- 3 sites in Ukraine
- Volunteers
- 9 people
- Sponsor
- Archivel Farma S.L.
Tuberculosis
TB Immunotherapy Trial With Heat-killed M. Vaccae
The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and…
- Trial name
- imm03 (NCT01977768)
- Testing
- V7
- Where
- 2 sites in Mongolia, Ukraine
- Volunteers
- 152 people
- Sponsor
- Immunitor LLC
Infection, Human Immunodeficiency Virus, HIV Infections
Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection
HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide.
- Trial name
- NCT02178592
- Testing
- DTG 50 mg, EFV 600 mg
- Where
- 28 sites in Argentina, Brazil and 5 more
- Volunteers
- 113 people
- Sponsor
- ViiV Healthcare
Tuberculosis
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis.
- Trial name
- NCT01585636
- Testing
- SQ109
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
Tuberculosis
Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above
This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above.
- Trial name
- NCT07152639
- Testing
- 5μg/ml EEC, 5 unit（U） EC, 5 IU TB-PPD
- Where
- 8 sites in China
- Volunteers
- 1,784 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Tuberculosis
Phase 1 Study of PBTZ169
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
- Trial name
- NCT03036163
- Testing
- PBTZ169 - 40 mg, PBTZ169 - 80 mg, PBTZ169 - 160 mg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Tuberculosis Diagnosis
Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children
In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases non-TB participants with lung disease who all meet the standard are divided into different groups through a randomized and blind method.
- Trial name
- NCT03027154
- Testing
- ESAT6-CFP10 in left arm and TB-PPD in right arm, ESAT6-CFP10 in right arm and TB-PPD in left arm
- Where
- 4 sites in China
- Volunteers
- 96 people
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Pulmonary Tuberculosis
Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated…
- Trial name
- NCT00401271
- Testing
- OPC-67683, Rifafour e-275
- Where
- 3 sites in South Africa
- Volunteers
- 54 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
HIV Infections
TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)
The purpose of this Phase I, open-label, single sequence drug-drug interaction trial in human immunodeficiency virus-type 1 infected patients is to investigate the potential interaction between steady-state nevirapine (NVP) 200…
- Trial name
- NCT00910806
- Testing
- TMC207; nevirapine
- Where
- South Africa
- Volunteers
- 16 people
- Sponsor
- Tibotec BVBA
Tuberculosis
Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)
The investigators recruit about 1800 cases participants who has signed ICF,then do some physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific gamma-interferon detection ,collection of medical…
- Trial name
- NCT02795260
- Testing
- Bacillus Calmette - Guerin
- Volunteers
- 1,802 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA