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NCT ID: NCT04605159 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

GRACE
Start date: November 20, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants will continue to be monitored as part of the study.

NCT ID: NCT04552899 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

STARSCAPE
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT04532749 Terminated - Clinical trials for Depressive Disorder, Major

A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of Seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

NCT ID: NCT04478266 Terminated - Breast Cancer Clinical Trials

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

AMEERA-5
Start date: October 14, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: - To compare the overall survival in both treatment arms. - To evaluate the objective response rate in both treatment arms. - To evaluate the duration of response in both treatment arms. - To evaluate the clinical benefit rate in both treatment arms. - To evaluate progression-free survival on next line of therapy. - To evaluate the pharmacokinetics of amcenestrant, and palbociclib. - To evaluate health-related quality of life in both treatment arms. - To evaluate the time to first chemotherapy in both treatment arms. - To evaluate safety in both treatment arms.

NCT ID: NCT04411472 Terminated - Clinical trials for Acute Kidney Injury Due to Sepsis

(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI

Start date: November 2, 2020
Phase: Phase 3
Study type: Interventional

Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis. The study has three distinct SA-AKI trial populations: 1. The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 2. A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 3. A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this population, COVID-19 should be the main cause of SA-AKI. In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients. There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.

NCT ID: NCT04390763 Terminated - Clinical trials for Metastatic Pancreatic Ductal Adenocarcinoma

Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

daNIS-1
Start date: October 16, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in untreated mPDAC.

NCT ID: NCT04374253 Terminated - Alzheimer Disease Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

NCT ID: NCT04338022 Terminated - Clinical trials for Relapsing Multiple Sclerosis

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Start date: June 12, 2020
Phase: Phase 3
Study type: Interventional

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

NCT ID: NCT04313881 Terminated - Clinical trials for Myelodysplastic Syndromes

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

ENHANCE
Start date: September 9, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

NCT ID: NCT04137887 Terminated - Clinical trials for Influenza (Healthy Volunteers)

Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older

Start date: November 4, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations. Secondary Objective: - To assess the clinical relative effectiveness of QIV-HD as compared to QIV-SD in prevention of: - inpatient hospitalization for selected circulatory and respiratory causes - death, either all-cause or cardiovascular or respiratory causes - inpatient hospitalization (using primary and secondary discharge diagnoses) - inpatient hospitalization (using admission diagnoses) - hospital emergency room visits - primary care visits to physician or - major acute cardiovascular events (MACE) - To assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by QIV-HD and QIV-SD groups. - To describe the clinical relative effectiveness of QIV-HD as compared to QIV-SD: - by age group and by group with specific comorbidities - for different periods of observation - To describe all serious adverse events (SAEs) (including adverse event of special interest [AESIs]) for all subjects in both QIV-HD and QIV-SD groups.