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  • TTVR STRONG Under Coverage With Evidence Development (CED) Study

    This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world. This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data. This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records. We will evaluate the primary outcome measure in various subgroups. There will be continued access enrollment after the primary completion date.

    Phase

    N/A

    Span

    407 weeks

    Sponsor

    Edwards Lifesciences

    Irvine, California

    Recruiting

  • GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder

    This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed dose clinical trial designed to evaluate the safety and efficacy of GATE-251 versus placebo in subjects with symptoms of major depressive disorder. Each subject will participate in this study up to 98 days: up to 28 days for screening, 42 days for double-blind treatment, and a 4-week follow-up period. Subjects will return to the clinic one time each week to have the severity of their depression assessed using the Hamilton depression rating scale-17. Adverse events that occurred since the last study visit will be recorded.

    Phase

    2

    Span

    100 weeks

    Sponsor

    Gate Neurosciences, Inc

    Irvine, California

    Recruiting

  • A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

    This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy. The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.

    Phase

    2

    Span

    262 weeks

    Sponsor

    Hoag Memorial Hospital Presbyterian

    Irvine, California

    Recruiting

  • PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)

    This study is a Phase 1b, randomized, double-blind, placebo controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (350 mg, 700 mg, and 1400 mg are planned). Patients will be randomly assigned 3:1, PMN310: placebo. Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.

    Phase

    1

    Span

    107 weeks

    Sponsor

    ProMis Neurosciences, Inc

    Irvine, California

    Recruiting

  • A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

    Phase

    2

    Span

    520 weeks

    Sponsor

    Janssen Pharmaceutica N.V., Belgium

    Irvine, California

    Recruiting

  • A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

    The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.

    Phase

    2

    Span

    379 weeks

    Sponsor

    Eli Lilly and Company

    Irvine, California

    Recruiting

  • A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

    Phase

    3

    Span

    327 weeks

    Sponsor

    Eli Lilly and Company

    Irvine, California

    Recruiting

  • The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

    Phase

    3

    Span

    253 weeks

    Sponsor

    Eli Lilly and Company

    Irvine, California

    Recruiting

  • Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder

    Phase

    3

    Span

    119 weeks

    Sponsor

    Neumora Therapeutics, Inc.

    Irvine, California

    Recruiting

  • Study to Assess the Safety and Effectiveness of NMRA-335140-501

    Phase

    3

    Span

    190 weeks

    Sponsor

    Neumora Therapeutics, Inc.

    Irvine, California

    Recruiting

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