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Found 14 Actively Recruiting clinical trials

A

Actively Recruiting

Researchers are evaluating the safety and effectiveness of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as a first treatment for people with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease, though prior therapy for locally advanced disease is allowed under certain conditions. The study excludes patients who have been treated with anti PD-(L)1 or anti-EGFR therapies except in specific cases. Participants will receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone as their first-line treatment for this condition. The study includes detailed eligibility criteria based on tumor location, PD-L1 expression, health status, and prior treatments. Treatment effects will be observed over time with a focus on overall survival and tumor response rates measured according to standard criteria. During the study, participants will undergo assessments including tumor biopsies, imaging scans to measure disease progression, heart function tests, and evaluations of organ function. Safety and treatment response will be closely monitored up to approximately three years. The study also tracks overall survival and tumor response rate as primary outcomes, ensuring continuous follow-up and support throughout the trial period.

Age: 18Years +All GendersPhase 3
202 locations
A

Actively Recruiting

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Age: 18Years +All GendersPhase 3
1117 locations
A

Actively Recruiting

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

Age: 18Years +All GendersPhase 3
151 locations
C

Actively Recruiting

Researchers are investigating the causes and clinical outcomes of acute febrile illness in patients older than 28 days living in rural areas of Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh. The study focuses on patients presenting with fever lasting 14 days or less, aiming to better understand the burden and factors affecting febrile illness in these low- and middle-income communities where infectious diseases remain a major health concern. This observational study is part of the South and Southeast Asian Community-based Trials Network and is funded by the UK Wellcome Trust. The study is conducted in two parts: Work Package A collects data from village health workers and local health facilities on the incidence and outcomes of febrile illness in the community, while Work Package B recruits patients from higher-level health facilities who are likely more severely ill. In Work Package B, a wide range of specimens, including blood and respiratory samples, will be collected for detailed diagnostic testing such as blood cultures, serology, molecular diagnostics, and host biomarker assays. These data will help create electronic decision-support tools to aid health workers in patient assessment and treatment. Participants will be closely monitored during their visit to health facilities where samples will be collected over approximately one month to determine the prevalence of pathogens causing febrile illness. Researchers will gather clinical data and laboratory results to analyze causes, incidence, and outcomes of fever in these rural settings. The study aims to improve future interventions by providing a rich understanding of febrile illness in these populations, with follow-up and safety monitoring incorporated in the study design.

Age: 29Days +All Genders
4 locations
C

Actively Recruiting

Atrial fibrillation (AF) is a common heart rhythm disorder that can lead to serious complications like stroke and bleeding. Asian patients with AF tend to have higher rates of major bleeding, including bleeding in the brain, compared to non-Asian patients. This research focuses on understanding the use of blood-thinning medications called anticoagulants, especially newer drugs known as non-vitamin K antagonist oral anticoagulants (NOACs), which are considered safer than warfarin but are less commonly used in Asian countries due to cost concerns. The study aims to track changes in how these medications are used and how they affect health outcomes over time. The study is a large, prospective observational registry conducted across 33 centers in Thailand, enrolling 3680 patients with non-valvular AF over two years. There is no intervention or treatment assigned by the study; instead, researchers observe patients' current treatments and outcomes. Participants will be followed every six months for a total of three years to monitor their use of warfarin and NOACs and record any serious events such as stroke, systemic embolism, major bleeding, heart attacks, heart failure, and overall quality of life. Throughout the study, patients will undergo regular assessments including clinical evaluations and monitoring of their medication use. The main outcomes measured over the three years include rates of using warfarin and NOACs, occurrence of ischemic stroke or transient ischemic attack, systemic embolism, intracranial hemorrhage, and major bleeding events. This long-term follow-up aims to provide valuable information on treatment patterns and safety in Asian patients with atrial fibrillation.

Age: 18Years - 100YearsAll Genders
33 locations
D

Actively Recruiting

Researchers are evaluating doravirine combined with tenofovir and lamivudine as an alternative to dolutegravir combined with tenofovir and lamivudine or emtricitabine in adults living with HIV-1 who have never received treatment before. This Phase III, open-label, randomized, non-inferiority trial is conducted in multiple countries including Brazil, Cameroon, Côte d'Ivoire, France, Mozambique, and Thailand. The study aims to compare the effectiveness of these regimens by measuring the control of HIV viral load at 48 weeks. Participants will be randomly assigned to receive either doravirine plus tenofovir and lamivudine or dolutegravir plus tenofovir and lamivudine or emtricitabine, all given orally. The study will follow 610 participants for a total of 96 weeks after starting antiretroviral therapy. Primary evaluation focuses on the proportion of participants who achieve a viral load below 50 copies/mL at week 48. Secondary assessments will be performed at weeks 48 and 96. During the trial, participants will undergo regular monitoring including laboratory tests to measure viral load and kidney and liver function. The study will also assess safety and adherence to treatment. Participants must provide informed consent and will be closely followed throughout the study duration to ensure accurate outcome measurements and safety monitoring.

Age: 18Years +All GendersPhase 3
19 locations
D

Actively Recruiting

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.

Age: 18Years - 75YearsAll GendersPhase 2
209 locations
E

Actively Recruiting

Researchers are evaluating the best dose of dolutegravir (DTG) for treating people who have both HIV and tuberculosis (TB) infections while taking rifampin (RIF) based anti-TB therapy. This Phase 2 study focuses on Thai patients newly diagnosed with pulmonary, pleural, or lymph node TB who have never received antiretroviral therapy (ART) before. The goal is to understand how DTG works in combination with RIF and find the optimal dose that will later be tested in a larger study for safety and effectiveness. The study has two stages. In the first stage, 40 HIV/TB patients will be randomly assigned to take either DTG 50 mg once daily with food or DTG 50 mg twice daily, both along with two other antiretroviral drugs. Researchers will closely monitor drug levels at week 4 and assess safety and tolerability. If results are promising, the study will proceed to stage two, enrolling 160 more patients randomized to the same two dosing groups. Drug concentrations will be checked at weeks 4 and 48, with ongoing safety and efficacy evaluations. Participants will be followed for at least 24 weeks, during which researchers will measure the amount of HIV in the blood to see how well the treatment suppresses the virus. Other assessments include laboratory tests for liver and kidney function, blood counts, and monitoring for side effects. The study also involves collecting data on how the drugs interact and the patients' overall health while on combination therapy for HIV and TB. Safety follow-up and interim analyses will guide the study's progress and ensure participant well-being.

Age: 18Years +All GendersPhase 2
10 locations
I

Actively Recruiting

Researchers are studying febrile illness in rural communities across South and Southeast Asia, including Cambodia, Laos, Myanmar, and Bangladesh. This extensive study aims to understand how common febrile illness is, what causes it, and what effects it has on people living in these areas. The research is funded by the UK Wellcome Trust and seeks to gather information on febrile illness on a scale never before attempted in these regions. The study focuses on Work Package A (WP-A), which operates at the community level by involving village health workers and small health centers. Patients who show signs of fever are recruited and assessed for symptoms. Since collecting specimens for diagnosis is challenging in these rural settings, the study uses finger-prick blood tests similar to existing rapid diagnostic tests, while also collecting dried blood spots for further testing. This approach helps identify various pathogens causing the febrile illness. Participants will be observed over time to track the incidence and outcomes of febrile illness. Researchers will measure how often febrile illness occurs locally and overall during the two-year period, as well as mortality and morbidity within one month after the patient first presents to a health worker or facility. The study involves clinical assessments and specimen collection to help improve future diagnosis and treatment of febrile illnesses in these communities.

All Genders
7 locations
L

Actively Recruiting

Healthy Volunteer

Researchers are studying the impact and cost-effectiveness of long-acting antiretrovirals for HIV prevention among Thai men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. The study involves three main parts: discrete choice experiments (DCE) to understand preferences for PrEP options, analysis of routine service data, and combining these results for epidemiological and economic evaluations. The goal is to understand what drives individual decisions about PrEP use and how new long-acting treatments might influence uptake compared to oral PrEP. The study includes several phases starting with in-depth interviews (IDIs) of 20 MSM and 20 TGW who are current or past PrEP users or interested in PrEP. These interviews identify important attributes of PrEP options. Next, focus group discussions (FGDs) with selected IDI participants refine these attributes. Then pilot testing of the DCE surveys is done with 30 MSM and 30 TGW to finalize the surveys. Finally, two separate surveys for MSM and TGW collect detailed information on sociodemographics, risk behaviors, PrEP knowledge, use, and preferences for different PrEP forms, dosing schedules, provider types, costs, and side effects. Participants will provide information through interviews, surveys, and discussions conducted in person or online. Researchers will analyze this data to estimate preferences and project how long-acting PrEP might affect uptake and cost-effectiveness over 12 months. The study measures epidemiological impact and economic value of these new prevention methods to inform future HIV prevention strategies in the key populations of Thailand.

Age: 18Years +MALEPhase Not Applicable
12 locations

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