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NCT ID: NCT04158648 Active, not recruiting - Hemophilia A Clinical Trials

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors

HAVEN 6
Start date: February 10, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).

NCT ID: NCT04157348 Active, not recruiting - Clinical trials for Eosinophilic Granulomatous Vasculitis

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

MANDARA
Start date: October 29, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).

NCT ID: NCT04157335 Active, not recruiting - Nasal Polyposis Clinical Trials

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

ORCHID
Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

NCT ID: NCT04157153 Active, not recruiting - Clinical trials for Coronary Artery Disease

First in Men Study: BIOMAG-I

Start date: April 27, 2020
Phase: N/A
Study type: Interventional

A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

NCT ID: NCT04156087 Active, not recruiting - Clinical trials for Pancreatic Cancer Non-resectable

Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer

MIMIPAC
Start date: May 9, 2020
Phase: Phase 2
Study type: Interventional

This phase-2 monocenter non-randomized prospective clinical trial evaluates the effectiveness of minimally invasive microwave ablation plus immunotherapy for unresectable non-metastatic locally advanced pancreatic cancer.

NCT ID: NCT04154956 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

CARMEN-LC03
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

NCT ID: NCT04153149 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.

NCT ID: NCT04152200 Active, not recruiting - Clinical trials for Primary Hyperoxaluria

A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1

ILLUMINATE-C
Start date: January 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).

NCT ID: NCT04148508 Active, not recruiting - Mental Disorder Clinical Trials

App-based Mental Health Promotion in Young European Adults

ECoWeB
Start date: October 9, 2020
Phase: N/A
Study type: Interventional

The ECoWeB Project aims to develop and disseminate a mobile application (App) to provide engaging and personalized tools and psychological skills to promote emotional wellbeing and prevent mental health problems in adolescents and young adults. The project team involves 8 European nations (the United Kingdom, Germany, Belgium, Spain, Greece, the Czech Republic, Denmark, and Switzerland) working together in order to improve mental health care and access for adolescents and young adults: - To use technology as a tool to assess and promote emotional well-being. - To deliver empirically supported psychological interventions through a smart phone application to address the needs of adolescents and young adults. - To improve mental well-being and prevent mental health problems in European adolescents and young adults. The ECoWeb project will consist of 2 RCT's within a longitudinal prospective cohort called ECoWeB-PROMOTE (indicating PROMOTION of well-being and good mental health) and ECoWeB-PREVENT (indicating PREVENTION of general distress, poor mental health and emotional disorders) respectively. These trials share the same recruitment procedure, interventions, outcomes (including self-report measures of well-being, anxiety, and depression) and design. Both are interested in the promotion of well-being and the prevention of general poor mental health in young people. The key difference is whether the participants are deemed to be at higher or lower risk criteria for poor mental health based on their general emotional competence skills, i.e., for those at low risk, do the interventions further enhance well-being, for those at higher risk, do the interventions prevent the worsening of poor mental health, general stress and distress, as well as enhancing well-being. In all cases the recruitment procedure will be the same, but the inclusion and exclusion criteria are different and the primary outcome measures are different hence they are 2 trials, rather than one, all running within the same cohort.

NCT ID: NCT04144387 Active, not recruiting - Clinical trials for Smoldering Multiple Myeloma

Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.

CARRISMM
Start date: February 11, 2020
Phase: N/A
Study type: Interventional

This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.