Search Bar & Filters
Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating a new tuberculosis preventive treatment among adolescents and school staff who have been in close contact with active TB cases. This study compares a novel 1-month ultra-short regimen called 1H3P3 with the standard 3-month 3HR regimen, aiming to prevent latent TB infection from progressing to active tuberculosis. The trial is a phase 3, multi-center, open-label, cluster randomized controlled study conducted in school settings in China, with the goal of improving TB prevention strategies for adolescents. Participants are randomly assigned to receive either the 12-dose 1H3P3 regimen of isoniazid and rifapentine taken three times a week for one month, or the 3HR regimen of isoniazid and rifampicin taken once daily for three months. Close contacts of TB cases are screened using blood tests, chest X-rays, sputum testing, and symptom checks to rule out active TB before enrollment. The treatment period lasts either one or three months depending on the group, followed by two years of follow-up to monitor for TB development. During the study, participants will undergo regular assessments including monitoring for active tuberculosis through clinical and laboratory tests, adverse events, treatment adherence, and drug resistance if active TB occurs. The main measurement is the cumulative incidence of active TB over 24 months after treatment begins. Safety and treatment completion rates are tracked throughout. Participation involves screening, treatment administration, and periodic follow-up visits over two years to evaluate outcomes and overall TB prevention effectiveness.
Actively Recruiting
Researchers are studying the rate of Mycobacterium tuberculosis MTB infection among students who have been in close contact with active tuberculosis ATB patients at school. The study also aims to identify risk factors related to tuberculosis infection and evaluate the health economics of the screening strategy. This observational study is sponsored by Huashan Hospital and focuses on school contacts of ATB patients aged 13 years and older. Participants will undergo the QuantiFERON-TB Gold QFT test to determine if they have been infected with MTB. Those who test positive will have further assessments including sputum Xpert MTBRIF testing, physical examination, chest CT scan, and if necessary, sputum culture to differentiate latent TB infection from active tuberculosis. For participants over 15 years old with a positive QFT result, a chest X-ray scan may also be performed. During the study, participants will provide baseline information including age, sex, vaccination history, contact patterns, and medical history through checklists. Researchers will monitor the prevalence of tuberculosis infection at baseline and collect other relevant data. The study is observational, meaning no treatment is provided, and participants will be followed to understand the infection status and related factors. The total study duration extends until the end of 2025.
Actively Recruiting
Researchers are evaluating TQB6411 Injection in adults with recurrent or metastatic Esophageal Cancer who have previously not responded to PD-1PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The study includes Phase Ib to assess tolerance and safety, and Phase II to evaluate the effectiveness of TQB6411 Injection in this participant group. Participants will receive TQB6411 Injection administered in treatment cycles of either 21 or 28 days. The study follows a single group model where all participants receive the investigational drug. The research aims to determine the recommended dose for Phase II, monitor adverse events, and assess progression-free survival over 24 months. Participants will be involved in treatment and regular assessments including laboratory tests, tumor measurements according to RECIST v1.1, and biomarker analysis using tumor tissue samples. The study measures include response rates, survival outcomes, and drug concentration in plasma. Safety monitoring continues for up to 24 months, and participants must comply with study procedures and contraception requirements during and after the study.