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Found 13 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying zelicapavir, a new oral medication that stops the replication of Respiratory Syncytial Virus RSV. This Phase 2 trial is evaluating zelicapavir as a potential treatment for RSV infection in children aged 28 days to 36 months who have symptoms of RSV. The study compares zelicapavir to a placebo to assess its effects and safety in both hospitalized and non-hospitalized children. Participants are randomly assigned to receive either zelicapavir oral suspension or a matching placebo once daily for 7 days. The study monitors the time it takes for RSV symptoms to completely resolve, along with other outcomes such as the severity of symptoms, viral load changes, and any hospitalizations during the study period. These assessments occur mainly from Day 1 through Day 14, with safety followed until Day 35. During the trial, caregivers and children will be assessed regularly to track symptom resolution and viral levels using specific measurement tools. Safety is carefully monitored by recording any adverse events up to Day 35. The study spans from the initial dosing period through follow-up visits, ensuring comprehensive evaluation of zelicapavirs potential in treating RSV in young children.

Age: 28Days - 36MonthsAll GendersPhase 2
8 locations
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Actively Recruiting

Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for 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 and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-L1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.

Age: 18Years +All GendersPhase 3
205 locations
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Actively Recruiting

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Age: 18Years +All GendersPhase 3
151 locations
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Actively Recruiting

Researchers are studying acute febrile illness in patients older than 28 days who live in rural areas of Laos, Myanmar, Thailand including the Thai-Myanmar border region, and Bangladesh. This observational study aims to describe the causes, clinical outcomes, and host biomarkers associated with these illnesses, which last 14 days or less. The study is part of a larger community-based network seeking to improve understanding and future interventions for febrile illness in low- and middle-income countries in South and Southeast Asia. The study involves two main parts Work Package A collects data from village health workers and local health facilities to understand the incidence and outcomes of febrile illness at the community level. Work Package B recruits patients seeking care at higher-level health facilities who may be more severely ill. In Work Package B, researchers collect various samples including venous blood and respiratory specimens for detailed diagnostic testing such as blood cultures, serological assays, molecular diagnostics, and host biomarker assays. Participants will be monitored for about one month to measure the prevalence of pathogens and recovery status. The study will analyze the association between host biomarkers and clinical outcomes to help create electronic decision-support tools for village health workers. These tools and other interventions will be tested later to improve assessment, triage, and treatment of patients with febrile illness. The total duration of participation and follow-up is approximately one month.

Age: 29Days +All Genders
4 locations
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Actively Recruiting

Atrial fibrillation AF is a major cause of heart-related illness and death, especially among Asian patients who face higher risks of serious bleeding such as brain hemorrhage compared to non-Asians. This research, called the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation COOL-AF Phase 2, aims to study how antithrombotic medication use changes over time and how these changes affect health outcomes in people with AF. The study is observational and conducted across multiple centers in Thailand. Participants in this study have known or newly diagnosed non-valvular AF and are followed without any intervention or treatment assigned by the study. The study plans to enroll about 3680 patients over two years from 33 centers. Participants will be monitored every 6 months for up to 3 years to observe patterns of medication use, particularly warfarin and non-vitamin K antagonist oral anticoagulants NOACs, and clinical events including stroke, systemic embolism, bleeding, heart attacks, and heart failure. Throughout the study, patients will have regular check-ins every six months to track their medication usage and health status. Researchers will collect data on important outcomes such as rates of stroke, bleeding events, and quality of life. The studys primary focus is on long-term safety and effectiveness of antithrombotic treatments in this population. The total participation duration can be up to 3 years, ensuring thorough observation of clinical outcomes and treatment patterns.

Age: 18Years - 100YearsAll Genders
33 locations
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Actively Recruiting

Researchers are evaluating doravirine as an alternative to dolutegravir in people newly diagnosed with HIV-1 infection who have not yet received treatment. This Phase III, open-label, randomized clinical trial aims to determine if doravirine combined with tenofovir and lamivudine is not less effective than dolutegravir combined with tenofovir and lamivudine or emtricitabine. The study will be conducted across multiple countries including Brazil, Cameroon, Cte dIvoire, France, Mozambique, and Thailand, enrolling 610 participants. Participants will be randomly assigned to one of two groups one receiving doravirine 100 mg plus tenofovir DF 300 mg and lamivudine 300 mg daily, and the other receiving dolutegravir 50 mg plus tenofovir DF 300 mg and either lamivudine or emtricitabine daily. The treatment period will last for 96 weeks after starting antiretroviral therapy ART, with primary assessment at week 48 to measure viral suppression. During the study, participants will undergo evaluations to monitor viral load, drug resistance, metabolic health, body weight changes, liver and kidney function, cardiovascular status, and mental health. Adherence to ART will be tracked, and blood samples will be taken to measure drug levels and immune cell counts. The research team will review virological efficacy and safety outcomes at weeks 48 and 96, supporting a comprehensive understanding of the treatments effects over nearly two years of participation.

Age: 18Years +All GendersPhase 3
19 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.

Age: 18Years - 75YearsAll GendersPhase 2
221 locations
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Actively Recruiting

Researchers are evaluating the best dose of dolutegravir DTG for treating people co-infected with HIV and tuberculosis TB who are also receiving rifampin RIF based TB therapy. This Stage II trial aims to understand how DTG behaves in the body when combined with RIF and to compare two dosing schedules of DTG in Thai patients newly diagnosed with pulmonary, pleural, or lymph node TB confirmed to be sensitive to RIF. The study will provide important information before moving on to a larger Stage III trial focused on safety and effectiveness.

Age: 18Years +All GendersPhase 2
10 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the epidemiological impact and cost-effectiveness of long-acting antiretrovirals for HIV prevention among Thai men who have sex with men MSM and transgender women TGW. The study includes discrete choice experiments DCEs to understand preferences for different pre-exposure prophylaxis PrEP options, as well as analysis of routine service data. The findings will guide mathematical modeling of long-acting PrEP uptake and its impact on HIV prevention. The study has three phases. Phase I involves in-depth interviews IDIs and focus group discussions FGDs with current, previous, or interested PrEP users to identify important attributes for PrEP choices. Phase II pilots the DCEs with convenience samples to refine the survey. Phase III launches two final surveys for MSM and TGW, collecting data on demographics, risk behavior, HIV and STI testing, PrEP knowledge, use, and preferences across attributes like product form, dosing frequency, provider type, and cost. Participants will take part in interviews, group discussions, and surveys conducted either in person or online. Data collected includes sociodemographic information, risk behaviors, PrEP attitudes, and preferences. Researchers will measure the projected uptake of long-acting PrEP, epidemiological impact, and cost-effectiveness over 12 to 18 months. The study includes ongoing monitoring of participant responses to optimize understanding of factors influencing PrEP use.

Age: 18Years +MALEPhase Not Applicable
12 locations
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Actively Recruiting

Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.

Age: 18Years +All GendersPhase 2Phase 3
261 locations

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