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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: NCT04604132 Terminated - Clinical trials for Gastric Adenocarcinoma

Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma

FIDES-03
Start date: October 6, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e. with human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring fibroblast growth factor receptor 2 (FGFR2) genetic aberrations (GA).

NCT ID: NCT04594707 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

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

STARSCAPE-OLE
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT04592341 Terminated - Alzheimer Disease Clinical Trials

A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.

NCT ID: NCT04583280 Terminated - Clinical trials for Respiratory Tract Infections

A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)

DAISY
Start date: September 6, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).

NCT ID: NCT04579666 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Start date: September 30, 2020
Phase: Phase 2
Study type: Interventional

This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

NCT ID: NCT04578548 Terminated - Clinical trials for Autosomal Dominant Polycystic Kidney Disease

A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Start date: November 10, 2020
Phase: Phase 2
Study type: Interventional

This is an exploratory, randomized, double-blind, placebo-controlled, parallel group, multicenter, proof of concept study (Phase 2a), evaluating orally administered GLPG2737 for a double-blind (DB) treatment period of 52 weeks and 4 weeks of follow up as well as an open-label extension (OLE) treatment period of 52 weeks and 4 weeks of follow-up, in subjects with rapidly progressing ADPKD.

NCT ID: NCT04566926 Terminated - Healthy Clinical Trials

A Study of JNJ-64140284 in Healthy Male Participants

AMPAR
Start date: September 29, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate and compare the pharmacokinetic (PK) profiles of a single dose of two solid dosage formulations of JNJ-64140284 in plasma and urine in healthy male participants under fed and fasting conditions; and to investigate the safety and tolerability of two solid dosage formulations of JNJ 64140284 versus placebo after single oral dose administration in healthy male participants under fed and fasting conditions in Part 1; to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (or 1 divided dose, if applicable) (ascending dose levels) in healthy male participants; and to characterize the PK of a single dose (or 1 divided dose, if applicable) of JNJ-64140284 in plasma in healthy male participants in Part 2; and to investigate the effect of food on the PK of a single (or 1 divided dose, if applicable) therapeutic relevant dose of JNJ 64140284 in healthy male participants; and to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration at a therapeutic relevant dose (or 1 divided dose, if applicable) in fed conditions in Part 3.

NCT ID: NCT04565717 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)

Start date: October 9, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients with NASH (Parts B and C).

NCT ID: NCT04558333 Terminated - Clinical trials for Primary Graft Dysfunction

CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation

Start date: October 28, 2019
Phase:
Study type: Observational

Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.