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NCT ID: NCT04939571 Recruiting - Clinical trials for Retinopathy of Prematurity

European Disease Registry on Retinopathy of Prematurity (ROP)

EU-ROP
Start date: August 6, 2021
Phase:
Study type: Observational [Patient Registry]

The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed. The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited. The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.

NCT ID: NCT04939428 Completed - Clinical trials for Coronavirus Disease (COVID-19)

Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)

MOVe-AHEAD
Start date: August 11, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.

NCT ID: NCT04938635 Withdrawn - Beta-Thalassemia Clinical Trials

Efficacy and Safety Study of Multiple Doses of VIT-2763 in Adults With Transfusion-dependent Beta-thalassemia

Start date: September 20, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of 3 multiple doses of VIT-2763 as measured by the reduction in red blood cell (RBC) transfusion burden from Week 13 to Week 24, to identify the most efficacious and safe dose.

NCT ID: NCT04936308 Recruiting - Clinical trials for Arthritis, Psoriatic

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

SOLSTICE
Start date: September 28, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

NCT ID: NCT04934072 Completed - Clinical trials for Postmenopausal Osteoporosis

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Start date: July 5, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period. For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.

NCT ID: NCT04932941 Completed - COVID-19 Clinical Trials

MP1032 Treatment in Patients With Moderate to Severe COVID-19

Start date: October 19, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to severe coronavirus disease 2019 (COVID-19).

NCT ID: NCT04932291 Completed - Clinical trials for Borderline Personality Disorder

Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population

Start date: March 26, 2021
Phase: Phase 2
Study type: Interventional

PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.

NCT ID: NCT04930094 Active, not recruiting - Clinical trials for Giant Cell Arteritis (GCA)

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)

NCT ID: NCT04929210 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

STAR
Start date: August 30, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.

NCT ID: NCT04928846 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Start date: March 25, 2022
Phase: Phase 3
Study type: Interventional

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.