Clinical Trials Logo

Filter by:
NCT ID: NCT05743881 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Start date: February 15, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to <24 months.

NCT ID: NCT05741346 Active, not recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Long-term Safety of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria

Start date: January 18, 2023
Phase: Phase 2
Study type: Interventional

This study is designed to provide continued access to BCX9930 for subjects currently receiving treatment with BCX9930 in a BioCryst-sponsored clinical study for paroxysmal nocturnal hemoglobinuria (PNH) who, in the opinion of the investigator, would benefit from continued treatment with BCX9930 and who do not have access to other treatment options.

NCT ID: NCT05739383 Recruiting - Clinical trials for Primary Prevention of Atherosclerotic Cardiovascular Disease

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Start date: March 9, 2023
Phase: Phase 3
Study type: Interventional

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

NCT ID: NCT05731128 Recruiting - Colitis Ulcerative Clinical Trials

A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype. Screening period: 2 to up to 4 weeks Treatment period: 52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.

NCT ID: NCT05723484 Recruiting - STI Clinical Trials

Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis

GIFT
Start date: June 1, 2023
Phase:
Study type: Observational

1. To evaluate the performance of a lateral flow POC test, namely the Genital InFlammation Test (GIFT), for identifying women with inflammatory STIs and BV, who are at higher risk of HIV infection and reproductive complications; 2. To evaluate how the GIFT device can be integrated in a feasible, acceptable, and cost-effective way into routine care.

NCT ID: NCT05722938 Recruiting - Clinical trials for Community-acquired Pneumonia

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

ESsCAPE
Start date: September 9, 2023
Phase: Phase 3
Study type: Interventional

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

NCT ID: NCT05722015 Active, not recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

Start date: February 14, 2023
Phase: Phase 3
Study type: Interventional

This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

NCT ID: NCT05714085 Recruiting - Heart Failure Clinical Trials

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

Start date: May 31, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

NCT ID: NCT05708261 Recruiting - HIV Clinical Trials

Tailoring Healthy Relationships to Improve HIV Outcomes

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This study will adapt the evidence-based intervention, Healthy Relationships, and then assess its feasibility using a pilot randomized controlled trial with HIV-positive MSM living with HIV in Eastern Cape, South Africa

NCT ID: NCT05705440 Recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control

Start date: February 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this follow-up study is to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905). No intervention will be administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the above-mentioned prior RSV MAT studies.